VENUS DIAMOND FLOW SYR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-09-10 for VENUS DIAMOND FLOW SYR manufactured by Heraeus Kulzer Gmbh.

Event Text Entries

[3742927] Please refer importer report # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[11200735] As allowed by exemption# (b)(4), (the importer) is submitting the report on behalf of heraeus kulzer (b)(4) (the mfr). Although we have not established that the device caused or contributed to the event, we're reporting it to be complaint with 21 cfr part 803 and out of an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610902-2013-00095
MDR Report Key3353174
Report Source05,07
Date Received2013-09-10
Date Mfgr Received2013-08-14
Date Added to Maude2013-09-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer ContactAUDI BOGUCKI, RDH
Manufacturer Street300 HERAEUS WAY
Manufacturer CitySOUTH BEND IN 46614
Manufacturer CountryUS
Manufacturer Postal46614
Manufacturer G1HERAEUS KULZER GMBH & CO. KG
Manufacturer StreetPHILIPP-REIS-STRASSE 8/13
Manufacturer CityWEHRHEIM D-61273
Manufacturer CountryGM
Manufacturer Postal CodeD-61273
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENUS DIAMOND FLOW SYR
Generic NameEBC SEALANT, PIT AND FISSURE, AND CONDI
Product CodeEBC
Date Received2013-09-10
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER GMBH
Manufacturer AddressWEHRHEIM GM


Patients

Patient NumberTreatmentOutcomeDate
10 2013-09-10

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