* SILIMED 120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-29 for * SILIMED 120 manufactured by Silimed.

Event Text Entries

[2857914] Explanted right and left gluteal implants due to infection. Findings: cracked left gluteal implant; bilateral capsular cavities with significant soft friable granulation tissue.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number2688969
MDR Report Key2688969
Date Received2012-07-29
Date of Report2012-07-29
Date of Event2012-04-10
Report Date2012-07-29
Date Reported to FDA2012-07-29
Date Added to Maude2012-08-09
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 Sequence Number: 1

Brand Name*
Generic NameELASTOMER, SILICONE BLOCK
Product CodeMIB
Date Received2012-07-29
Returned To Mfg2012-06-25
Model NumberSILIMED 120
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityR
Device Age8 YR
Device Sequence No1
Device Event Key0
ManufacturerSILIMED
Manufacturer Address6769 HOLLISTER AVE SUITE 201 SANTA BARBARA CA 93117 US 93117

Device Sequence Number: 2

Brand NameRIGHT GLUTEAL
Generic NameELASTOMER, SILICONE BLOCK
Product CodeMIB
Date Received2012-07-29
Returned To Mfg2012-06-25
Model NumberSILIMED 120
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityR
Device Age8 YR
Device Sequence No2
Device Event Key0
ManufacturerSILIMED
Manufacturer Address6769 HOLLISTER AVE SUITE 201 SANTA BARBARA CA 93117 US 93117

Patients

Patient NumberTreatmentOutcomeDate
10 2012-07-29
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