STYLE68 - LOW PROFILE 2568151 STYLE 68, LOW PROFILE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-11 for STYLE68 - LOW PROFILE 2568151 STYLE 68, LOW PROFILE manufactured by Mcghan Medical Corp..

Event Text Entries

[19492785] 01/19/99: bilateral saline mammary implants surgically placed. The left breast implant slowly but progressively lost volume until it was obvious that the implant was failing. 03/04/99: failed left mammary implant was explanted. Identical replacement was inserted. Pathology evaluation of device revealed a partially collapsed silastic breast implant.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number214233
MDR Report Key214233
Date Received1999-03-11
Date of Report1999-03-10
Date of Event1999-03-04
Date Facility Aware1999-03-04
Report Date1999-03-10
Date Reported to FDA1999-03-10
Date Reported to Mfgr1999-03-10
Date Added to Maude1999-03-17
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 NameSTYLE68 - LOW PROFILE
Generic NameMAMMARY IMPLANT
Product CodeFWN
Date Received1999-03-11
Returned To Mfg1999-03-10
Model Number2568151
Catalog NumberSTYLE 68, LOW PROFILE
Lot NumberLEFT 3426
ID Number150 CC SALINE
OperatorOTHER
Device AvailabilityR
Device Age42 DAY
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key207814
ManufacturerMCGHAN MEDICAL CORP.
Manufacturer Address700 WARD DR SANTA BARBARA CA 931112936 US

Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1999-03-11
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