SILICONE INJECTOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-20 for SILICONE INJECTOR manufactured by Unknown.

Event Text Entries

[19803] Several infections of silicone were made into each breast & substance silicone has separated into small floating particles in the breast area. Dr unable to evaluate mammograms.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4000726
MDR Report Key26963
Date Received1995-07-20
Date of Report1995-03-01
Date of Event1964-01-01
Date Added to Maude1995-10-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSILICONE INJECTOR
Generic NameINJECTOR
Product CodeKGM
Date Received1995-07-20
Device AvailabilityN
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key27748
ManufacturerUNKNOWN
Manufacturer Address*


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 1995-07-20

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