MAUDE Adverse Event Report: INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	SRLP-440
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	12/15/2020
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.The event of capsular contracture 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: capsular contracture, baker grade iv.
Event or Problem Description
Patient reported left side capsular contracture, baker grade iv.Healthcare professional reported and confirmed the event.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified crease folds.A weight test of the device verified the device was within specification.Cloudiness after the autoclave disinfection process was observed in the gel.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.
Event or Problem Description
Patient reported left side capsular contracture, baker grade iv.Healthcare professional reported and confirmed the event.Device has been explanted.
Event or Problem Description
Patient reported left side capsular contracture, baker grade iv.Healthcare professional reported and confirmed the event.Device has been explanted.

• Brand Name: INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• MDR Report Key: 11315115
• Report Number: 9617229-2021-00805
• Device Sequence Number: 16358444
• Product Code: FTR
• UDI-Device Identifier: 10888628006959
• UDI-Public: 10888628006959
• 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: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2021

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: 10/28/2023
• Device Model Number: SRLP-440
• Device Catalogue Number: SRLP-440
• Device Lot Number: 3285177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/18/2021; 09/30/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/18/2021; 10/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2018
• 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 Weight: 93