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

Model Number	TSM-405
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event of necrosis 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: "crack in the device with silicone gel tampering" and breast necrosis.
Event or Problem Description
Patient representative reported "visibility of the shell," "insomniating and radiating breast pain in the upper limbs", and a "crack in the left side device with silicone gel tampering" (diagnosed by ultrasound/mammography).Device has been explanted."evidence of silicone blade" seen after capsulectomy.Patient experienced "pruritus and skin lesions on the left upper limb suggesting a silicone gel allergy." patient received "local treatment." also reported "painful after-effects related to the presence of silicone and breast necrosis, unattractive results, and inconvenience/feels discomfort in everyday tasks.".

• 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: 10382459
• Report Number: 9617229-2020-12208
• Device Sequence Number: 3669747
• Product Code: FTR
• UDI-Device Identifier: 10888628033962
• UDI-Public: 10888628033962
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

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 Model Number: TSM-405
• Device Catalogue Number: TSM-405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/07/2020
• 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
• Patient Age: 25 YR