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

Catalog Number	N-TSF385
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported, the device was replaced, "due to the risk of becoming ill".Healthcare professional, later reported, capsular contracture, baker grade iii and rippling.The device has been explanted and replaced with another manufacturer's device.This record relates to the left side.
Additional Manufacturer Narrative
The event of capsular contracture 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: capsular contracture, grade 3.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d4, h4, h6 a review of the device history record has been completed.No deviations or non-conformances noted.Photographic device evaluation: a review of the device through photographs noted the event of anxiety and capsular contracture could not be observed as it is a physiological complication.The event of wrinkling was not observed.
Event or Problem Description
Patient reported the device was replaced "due to the risk of becoming ill." healthcare professional later reported left side capsular contracture, baker grade iii, and rippling.The device has been explanted and replaced with another manufacturer's device.

• 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; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 19736050
• Report Number: 9617229-2024-16768
• Device Sequence Number: 20926744
• Product Code: FTR
• UDI-Device Identifier: 10888628034143
• UDI-Public: 10888628034143
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 09/19/2019
• Device Catalogue Number: N-TSF385
• Device Lot Number: 2654023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/20/2024
• Date Device Manufactured: 09/19/2014
• 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: 29 YR
• Patient Sex: Female