SILASTIC IMPLANT 4880205

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-03 for SILASTIC IMPLANT 4880205 manufactured by Wright Dow Corning.

Event Text Entries

[14204] Wrist implant removed due to breakage of device. Implanted 6 yrs ago. Pt denies history of trauma/incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number26610
MDR Report Key26610
Date Received1995-08-03
Date of Report1995-05-11
Date of Event1995-05-10
Date Added to Maude1995-10-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSILASTIC IMPLANT
Generic NameWRIST IMPLANT
Product CodeKWM
Date Received1995-08-03
Catalog Number4880205
Lot NumberHH126320
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Age*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key27359
ManufacturerWRIGHT DOW CORNING
Manufacturer Address5677 AIRLINE RD ARLINGTON TN 38002 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 1995-08-03

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