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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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ALLERGAN (COSTA RICA) INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED Back to Search Results
Catalog Number TSM-485
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code Failure of Implant (1924)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: rupture.This is a known potential adverse event addressed in the product labeling.
 
Event or Problem Description
Patient reported left side rupture and "word slurring".The device remains implanted.
 
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Brand Name
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Common Device Name
PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
Manufacturer (Section D)
ALLERGAN (COSTA RICA)
900 parkway global park
zona franca
CS 
MDR Report Key8692369
Report Number9617229-2019-06065
Device Sequence Number1935736
Product Code FTR
UDI-Device Identifier10888628033986
UDI-Public10888628033986
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
P020056
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source consumer,foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue NumberTSM-485
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/14/2019
Initial Report FDA Received Date06/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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