MAUDE Adverse Event Report: UNKNOWN ALLERGAN INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NON-INFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	SSM-600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported, via nbir ¿skin necrosis¿.This record is for the left side.Device was explanted.
Additional Manufacturer Narrative
The event of skin 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: skin necrosis.

• Brand Name: INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NON-INFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): UNKNOWN ALLERGAN; 900 parkway global park zona f; la aurora de heredia ; CS
• Manufacturer (Section G): UNKNOWN ALLERGAN; 900 parkway global park zona f; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18899108
• Report Number: 9617229-2024-04303
• Device Sequence Number: 7682511
• Product Code: FTR
• UDI-Device Identifier: 10888628033016
• UDI-Public: 10888628033016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

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 Catalogue Number: SSM-600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White