FUNDUS FCPS DA 5MM INLINE * 9010-600-107IL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2003-09-15 for FUNDUS FCPS DA 5MM INLINE * 9010-600-107IL manufactured by Koscher & Wurtz Gmbh.

Event Text Entries

[303218] The distributor reported that on both instruments the hinge broke during use. There was no pt injury whatsoever.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010877-2003-00002
MDR Report Key489778
Report Source08
Date Received2003-09-15
Date of Report2003-09-08
Date Mfgr Received2003-04-09
Device Manufacturer Date2002-11-01
Date Added to Maude2003-10-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactSTEFAN KOSCHER
Manufacturer StreetEINSTEINSTR 7
Manufacturer CitySPAICHINGEN 78549
Manufacturer CountryGM
Manufacturer Postal78549
Manufacturer Phone424958300
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFUNDUS FCPS DA 5MM INLINE
Generic Name*
Product CodeHCZ
Date Received2003-09-15
Model Number*
Catalog Number9010-600-107IL
Lot Number0300084
ID Number*
Device Availability*
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key478524
ManufacturerKOSCHER & WURTZ GMBH
Manufacturer AddressEINSTEINSTRASSE 7 SPAICHINGEN GM 78549
Baseline Brand NameFUNDUS FCPS DA 5MM INLINE
Baseline Generic Name*
Baseline Model No*
Baseline Catalog No9010-600-107IL
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 2003-09-15

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