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

Model Number	TRM-375
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been completed.No deviations or non-conformances noted.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: "possible gel bleed".
Event or Problem Description
Patient representative reported left side concern with product.Healthcare professional reported mri indicates left side "possible gel bleed." device was explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: the device related to the reported anxiety-product/procedure and gel bleed was received august 30, 2022, with lot number 2979059.Analysis of the returned device identified: weight to the spec and deformation device.No other observation observed.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.
Event or Problem Description
Patient representative reported left side concern with product.Healthcare professional reported mri indicates left side "possible gel bleed." device was explanted and replaced.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 15317252
• Report Number: 9617229-2022-14656
• Device Sequence Number: 20134530
• Product Code: FTR
• UDI-Device Identifier: 10888628008120
• UDI-Public: 10888628008120
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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 Expiration Date: 09/25/2021
• Device Model Number: TRM-375
• Device Catalogue Number: TRM-375
• Device Lot Number: 2979059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2016
• 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 Sex: Female
• Patient Weight: 87 KG