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

Catalog Number	TCF-695
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Necrosis (1971)
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.The event of capsular contracture, lump/nodule and necrosis are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.The reason for reoperation: "a lump," further clarified as "knot was the size of a marble," "necrosis" "experiencing pain in both breasts, and 'capsular contracture, [baker grade unknown]" and feel "very hard".Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.These are known potential adverse events addressed in the product labeling.
Event or Problem Description
Patient reported "a lump," further clarified as "knot was the size of a marble," "necrosis" "experiencing pain in both breasts, worse on the left and 'capsular contracture, [baker grade unknown]" and feel "very hard".Device remains implanted.This record is for the left side.

• Brand Name: INSPIRA TEXTURE COHESIVE 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: 9475767
• Report Number: 9617229-2019-17699
• Device Sequence Number: 2751724
• Product Code: FTR
• UDI-Device Identifier: 10888628031197
• UDI-Public: 10888628031197
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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: 08/14/2021
• Device Catalogue Number: TCF-695
• Device Lot Number: 2961148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 12/16/2019
• 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