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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Seroma (2069)
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.The events of seroma-late and abscess are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Reason for reoperation: "large pocket of fluid build up", "some swelling around the nipple", "a large amount of puss coming out of the lining of her previous scar due to a mastopexy" and exchange due to concern with textured product.
Event or Problem Description
Patient reported left side "large pocket of fluid build up", "some swelling around the nipple", "a large amount of puss coming out of the lining of her previous scar due to a mastopexy" and exchange due to concern with textured product.Device remains 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; CS
• MDR Report Key: 10103448
• Report Number: 9617229-2020-08135
• Device Sequence Number: 3082522
• Product Code: FTR
• UDI-Device Identifier: 10888628008632
• UDI-Public: 10888628008632
• Combination Product (Y/N): N
• Initial Reporter State: CT
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2020

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: 01/04/2021
• Device Model Number: TRX-800
• Device Catalogue Number: TRX-800
• Device Lot Number: 2865541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention