MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 68 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	68-150
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/20/2021
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 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: deflation.
Event or Problem Description
Healthcare professional reported a left side deflation.Device was explanted.
Event or Problem Description
Healthcare professional additionally reported "any creases.".
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified; fold creases.The leak test and microscopic analysis was performed which identified; a curved sharp opening on patch bond edge assessed as unidentified (tear) opening (a dimension measurement in the shell was performed which identify the thickness within specification), wear abrasion, partial delamination of diapherm flange disk assessed as adhesive failure.Based on the device analysis the final assessment is: a sharp opening assessed as unidentified (tear) opening.Delamination of diapherm flange disk assessed as adhesive failure.
Event or Problem Description
Healthcare professional reported a left side deflation.Device was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d6b.

• Brand Name: STYLE 68 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12385969
• Report Number: 9617229-2021-49452
• Device Sequence Number: 11985014
• Product Code: FWM
• UDI-Device Identifier: 10888628000162
• UDI-Public: 10888628000162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2021

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: 11/15/2019
• Device Model Number: 68-150
• Device Catalogue Number: 68-150
• Device Lot Number: 2843527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/09/2021; 11/30/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/06/2021; 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2015
• 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: 52 YR
• Patient Sex: Female