MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	TSM-360
Medical Device Problem Codes	Gel Leak (1267); Material Rupture (1546)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event of "seroma" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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 and seroma.
Event or Problem Description
Explanting surgeon reports "rupture and capsular contracture baker grade ii on the left side, silicon perspiration on the left side, pain, inflammation and seroma-late".The implants have been removed.

• 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; la aurora de heredia ; CS
• Manufacturer (Section G): UNKNOWN ALLERGAN; 900 parkway global park zona f; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; austin, TX ; 8479375615
• MDR Report Key: 15358800
• Report Number: 9617229-2022-32043
• Device Sequence Number: 20200493
• Product Code: FTR
• UDI-Device Identifier: 10888628033948
• UDI-Public: 10888628033948
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2022

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 Number: TSM-360
• Device Catalogue Number: TSM-360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 09/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female