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

Model Number	TRX-800
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: rupture, anxiety/textured.
Event or Problem Description
Patient reported left side rupture, exchange from textured due to concern with product, and "achy".Patient also reported the non device related events of "hand tingling", "sinus problems, hair loss", and "allergies".The device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, b6, d6b, d9, h6.
Event or Problem Description
The device has been explanted.
Event or Problem Description
Patient reported left side rupture, exchange from textured due to concern with product, and "achy".Patient also reported the non device related events of "hand tingling", "sinus problems, hair loss", and "allergies".Patient additionally reported "cyst", and "allergic reaction/hypersensitivity." the device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: observed, broken on the radius side assessed as unidentified (tear) opening.(shell thickness was within specification).Anxiety-product/procedure: unable to observe since it is a medical event and is not related to the device.Pain: unable to observe since it is a medical event and is not related to the device.Sensation increase/decrease-ndr: not applicable as the event is not related to the device.Varied injuries-ndr: not applicable as the event is not related to the device.Additional observations: red particle observed on the gel.Red particle observed on the device.No further actions are required as the device was implanted.

• 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: 15744313
• Report Number: 9617229-2022-19603
• Device Sequence Number: 17474990
• Product Code: FTR
• UDI-Device Identifier: 10888628008632
• UDI-Public: 10888628008632
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2023

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: 01/13/2021
• Device Model Number: TRX-800
• Device Catalogue Number: TRX-800
• Device Lot Number: 2868752
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 01/12/2023; 02/08/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/31/2023; 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2016
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Weight: 84 KG