MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 40 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	40-320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.Reason for reoperation is pain.The event of pain 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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported left side "pain".The device has been explanted.
Event or Problem Description
Healthcare professional reported left side "pain".The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified; flat creases, deformation, the weight the device within specification and was observed after autoclave: cloudy color and bubbles.Based on the device analysis the final assessment is: no issues to be found related with the manufacturing process.

• Brand Name: STYLE 40 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: 8687704
• Report Number: 9617229-2019-06644
• Device Sequence Number: 19422810
• Product Code: FTR
• UDI-Device Identifier: 10888628001930
• UDI-Public: 10888628001930
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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: 06/16/2020
• Device Catalogue Number: 40-320
• Device Lot Number: 2777045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/09/2019
• 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