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

Model Number	SCLP-250
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/11/2019
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 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 iii.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported capsular contracture, baker's grade iii.The device was explanted.This record is for the right side.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified deformation and creases.A weight test of the device was completed and the device was within specification.Cloudiness after autoclave disinfection process in the gel was observed.Based on the device analysis, the final assessment is no issues found related with the manufacturing.
Event or Problem Description
Healthcare professional reported capsular contracture, baker's grade iii.The device was explanted.This record is for the right side.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a.4., b.5., b.6., g.1., h.6.
Event or Problem Description
Additionally, healthcare professional reported "patient is unhappy with results".

• Brand Name: INSPIRA SMOOTH 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: 9203720
• Report Number: 9617229-2019-17461
• Device Sequence Number: 2589636
• Product Code: FTR
• UDI-Device Identifier: 10888628029668
• UDI-Public: 10888628029668
• Combination Product (Y/N): N
• Initial Reporter State: NC
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2021

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: 07/27/2023
• Device Model Number: SCLP-250
• Device Catalogue Number: SCLP-250
• Device Lot Number: 3243521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 02/24/2021
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 12/28/2019; 03/24/2021
• 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: 36 YR
• Patient Weight: 51