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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
Model Number TSF-220
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code Failure of Implant (1924)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Reason for reoperation: rupture.Further information from the reporter regarding the events, product, and patient details have been requested.No additional information is available at this time.(b)(6).
 
Event or Problem Description
Healthcare professional reported a right side capsular rupture.Patient is pregnant and lactating at time of event.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 Key9881501
Report Number9617229-2020-05389
Device Sequence Number11487327
Product Code FTR
UDI-Device Identifier10888628034075
UDI-Public10888628034075
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
P020056
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/25/2020
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 Model NumberTSF-220
Device Catalogue NumberTSF-220
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/25/2020
Initial Report FDA Received Date03/25/2020
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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