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

Model Number	FF-410475
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
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.The reason for reoperation was/is capsular contracture baker grade iii/iv, implant has fallen from original location and voluntary recall allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.
Event or Problem Description
Patient reported a left side "implant has fallen from its original location ".Healthcare professional reported capsular contracture baker grade iii/iv and explant due to "voluntary recall".Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: deformation device, creases fold, green biological tissue, cloudy in the gel and overweight.However, a review of the weight reports generated during the manufacturing process is performed and all units were within specification.Therefore, the overweight observed during the additional analysis is not considered a workmanship.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.
Event or Problem Description
Patient reported a left side "implant has fallen from its original location ".Healthcare professional reported capsular contracture baker grade iii/iv and explant due to "voluntary recall".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 (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9481739
• Report Number: 9617229-2019-22292
• Device Sequence Number: 18906434
• Product Code: FTR
• UDI-Device Identifier: 10888628002692
• UDI-Public: 10888628002692
• Combination Product (Y/N): N
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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: 11/08/2019
• Device Model Number: FF-410475
• Device Catalogue Number: FF-410475
• Device Lot Number: 2678851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/27/2020
• 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