MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 168 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	168-450
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Reason for reoperation was due to deflation.A review of the device history record has been completed.No deviations or non-conformances noted.This is a known potential adverse event addressed in the product labeling.Device evaluation: visual analysis of the returned device identified: crease fold, opening and yellow particles.Leak test was performed and found opening on posterior.A microscopic analysis was performed which identify sharp edge opening assessed as unidentified tear opening.A dimension measurement in the shell was performed which identify the thickness within specification.The fill test inspection was performed, the result is no blockage.Based on the device analysis the final assessment is a sharp opening on posterior side due to an unidentified (tear) opening.
Event or Problem Description
Healthcare professional reported a right side deflation.Device has been expected.

• Brand Name: STYLE 168 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9467332
• Report Number: 9617229-2019-14737
• Device Sequence Number: 11302601
• Product Code: FWM
• UDI-Device Identifier: 10888628000865
• UDI-Public: 10888628000865
• Combination Product (Y/N): N
• Initial Reporter State: NC
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

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: 06/14/2019
• Device Catalogue Number: 168-450
• Device Lot Number: 2773174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 12/13/2019
• 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