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Mutmaßung
EU-Kommissionswerk
Aug 17, 2017 19:33
6 yrs ago
6 viewers *
German term

Bekanntwerden

German to English Medical Medical (general) Surgical outcomes
I have another question about FDA Medical Device Reporting. The document I am working on states that there are three types of incidents, of which a Mutmaßung is one (definition from the document: Ein Angestellter der Organisation hat Informationen erworben, die die Vermutung zulassen, dass ein meldepflichtiges unerwünschtes Ereignis stattgefunden hat.)

I have tried searching the FDA MDR site, but I am unable to find the exact translation of the terms for incident classification - perhaps someone can assist?
Any help will be appreciated!

Thanks,
Sarai
Proposed translations (English)
3 Incident reporting
3 (public) notice
3 disclosure of adverse event reports ( as the heading)

Discussion

Dr Sarai Pahla, MBChB (asker) Aug 18, 2017:
Wow, you guys went above and beyond! Thank you so much to everyone, and thanks to herbalchemist for finding the appropriate link! This is what makes this community so valuable.
Karolin Schmidt Aug 18, 2017:
Great job : )
Herbmione Granger Aug 17, 2017:
presumption, public disclosure, complaint Repost from Mutmaßung, Medical Device Reporting for Manufacturers: (PDF) https://www.fda.gov/downloads/medicaldevices/deviceregulatio...
More material for David's growing off the screen answer?
David Hollywood Aug 17, 2017:
btw I agree with Phil on "suspicion" despite my earlier post
Dr Sarai Pahla, MBChB (asker) Aug 17, 2017:
Both excellent suggestions! The third is "Beschwerde", which I interpret as complaint. What do you think? Really appreciate your help!
philgoddard Aug 17, 2017:
In that case How about "knowledge"? And your previous question could be "suspicion". What is the third?
Dr Sarai Pahla, MBChB (asker) Aug 17, 2017:
Oh dear - thanks for pointing this out, Phil! I copied the text from the question on Mutmaßung and didn't proofread my own question because I am trying to rush to bed!! BAD! The definition refers to Bekanntwerden. The title is Bekanntwerden, and the definition is " Ein Angestellter der Organisation hat Informationen erworben, die die Vermutung zulassen, dass ein meldepflichtiges unerwünschtes Ereignis stattgefunden hat." That is all the text on this topic.
philgoddard Aug 17, 2017:
Hi Sarai Your text doesn't contain the word Bekanntwerden!

Proposed translations

1 hr
Selected

Incident reporting

Incidents become known when they're reported. Boy, that was insightful..:)
Something went wrong...
4 KudoZ points awarded for this answer. Comment: "It certainly was - it earned you 4 kudos points :)"
45 mins

(public) notice



Ein Angestellter der Organisation hat Informationen erworben, die die Vermutung zulassen, dass ein meldepflichtiges unerwünschtes Ereignis stattgefunden hat.

An FDA employee has received information that does not rule out (the possibility) that a reportable adverse event has occurred.

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Note added at 48 mins (2017-08-17 20:22:09 GMT)
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a linguee ref so alwazs has to be taken with a pinch of salt but ok IMO

Auf diese Weise kann ein öffentliches Bekanntwerden des Konflikts unterbunden werden und damit zugleich ein möglicher Imageschaden [...] pfk.at

Consequently public notice of the conflict together with possible damage for the image of the involved person or company can be prevented.

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Note added at 51 mins (2017-08-17 20:24:26 GMT)
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"unerwünschtes Ereignis" is "adverse event" in FDA-speak

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Note added at 52 mins (2017-08-17 20:25:56 GMT)
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and not only FDA:

https://de.wikipedia.org/.../Schwerwiegendes_unerwünschtes_E...
Traducir esta página
Ein schwerwiegendes unerwünschtes Ereignis (SUE) (von englisch serious adverse event, SAE) ist ein schwerwiegender Vorfall, der im Rahmen einer ...
‎Rechtliche Vorgaben · ‎Bekannte ...
[PDF]Meldung von Serious Adverse Events (SAE ... - CAO/ARO/AIO-04
www.rektumkarzinom.med.uni-erlangen.de/.../Vortrag_SAE.pdf

Begrifflichkeiten 3. Schwerwiegendes Unerwünschtes Ereignis /. Serious Adverse Event / SAE nach GCP-V § 3 (8):. Schwerwiegendes unerwünschtes Ereignis ...

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Note added at 55 mins (2017-08-17 20:28:25 GMT)
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https://www.accessdata.fda.gov/scripts/cdrh/.../CFRSearch.cf...

(a) Definitions. The following definitions of terms apply to this section: Adverse drug experience. Any adverse event associated with the use of a drug in humans, ...

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Note added at 1 hr (2017-08-17 20:33:46 GMT)
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and back to "die die Vermutung zulassen" could be rendered as "allow the presumption" ... lots of wazs to do this bit, so up to you

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Note added at 1 hr (2017-08-17 20:34:43 GMT)
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with Phil and Kim on this too, we'll get there :)

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Note added at 1 hr (2017-08-17 20:37:23 GMT)
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sorry about the zzzs, was on German keyboard

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Note added at 1 hr (2017-08-17 20:59:46 GMT)
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if "Bekanntwerden" is a heading, ok but we would really need the full context

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Note added at 1 hr (2017-08-17 21:09:54 GMT)
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maybe "announcement" but hard to say
Note from asker:
Thank you so much for the helpful references! This was very informative - I went in a different direction on this one but believe this is very accurate.
Something went wrong...
4 days

disclosure of adverse event reports ( as the heading)

see the Transparency Report 2010-05-19 pdf, page 18, #3. "...if preliminary event information from adverse event reports is disclosed..."

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Note added at 5 days (2017-08-22 20:58:13 GMT)
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My apologies, I hadn't seen the discussion before I posted this. Herbalchemist had already pointed out the link and wording. The downside of checking this stuff on the mobile app is that you don't see everything. At least I don't, or I'm just not so savvy.
Example sentence:

going off of David's sentence: "an FDA employee ( or official) has received the information that, presumably, a reportable adverse evevt has occured..." this as the text, with "disclosure of adverse event reports" as the heading

Reference:

http://https://google2.fda.gov/search?q=Public+notice+of+possible+adverse+events&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requir

Note from asker:
This answer was actually my personal favourite in terms of wording - had it been an EMA document, this would have been it!
Something went wrong...
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