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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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ALLERGAN (COSTA RICA) INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED Back to Search Results
Catalog Number SSL-110
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 12/20/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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.
 
Event or Problem Description
Healthcare professional reported a left side rupture.Device has been explanted.
 
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Brand Name
INSPIRA SMOOTH 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 Key9582570
Report Number9617229-2019-23332
Device Sequence Number19644327
Product Code FTR
UDI-Device Identifier10888628032477
UDI-Public10888628032477
Combination Product (Y/N)N
Initial Reporter StateWA
PMA/510(K) Number
P020056
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
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 Expiration Date04/17/2023
Device Catalogue NumberSSL-110
Device Lot Number3203931
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/20/2019
Initial Report FDA Received Date01/13/2020
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;
Patient Age43 YR
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