MAUDE Adverse Event Report: ALLERGAN (AUSTIN) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	FF-410290
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Abscess (1690); Capsular Contracture (1761); Cellulitis (1768)
Date of Event	08/09/2019
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.Device evaluation: analysis of the returned device identified: weight to the spec, deformation device and brown particles in the device.Cloudy and voids in the gel observed after autoclave cycle based on the device analysis the final assessment is: no issues found related with the manufacturing process the events of capsular contracture baker grade unknown, cellulitis and abscess are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Reason for reoperation: patient¿s concern with the product, capsular contracture baker grade unknown , cellulitis and abscess of the breast, and increased risk of alcl.
Event or Problem Description
Health professional reported right side exchange from textured to smooth implant due to the patient¿s concern with the product.Later, patient representative reported, "capsular contracture baker grade unknown requiring bilateral capsulectomy, cellulitis and abscess of the breast, and increased risk of alcl." the device has been explanted.

• Brand Name: STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (AUSTIN); 12331-a riata trace parkway; building 3; austin TX 78727
• Manufacturer (Section G): ALLERGAN (AUSTIN); 12331-a riata trace parkway; building 3; austin TX 78727
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 14885758
• Report Number: 9617229-2022-11395
• Device Sequence Number: 17688975
• Product Code: FTR
• UDI-Device Identifier: 10888628002654
• UDI-Public: 10888628002654
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2022

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: 09/22/2019
• Device Model Number: FF-410290
• Device Catalogue Number: FF-410290
• Device Lot Number: 2666227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 54 YR
• Patient Sex: Female