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

Model Number	168-510
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/12/2020
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.The reason for reoperation: deflation.
Event or Problem Description
Healthcare professional reported left side deflation.Device has been explanted.
Event or Problem Description
Healthcare professional reported left side deflation.Device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: visual analysis of the returned device identified an opening and crease fold.Leak test was performed and identified an opening on anterior.A microscopic analysis was performed which identified a striated edge opening consistent with the use of a surgical tool, and a sharp opening in the anterior side.Fill test inspection was performed and the result was no blockage.Based on the device analysis the final assessment was a striated edge opening on anterior assessed as surgical damage, and a sharp opening assessed as an unidentified (tear) opening.

• 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: 9701520
• Report Number: 9617229-2020-01322
• Device Sequence Number: 16644565
• Product Code: FWM
• UDI-Device Identifier: 10888628000889
• UDI-Public: 10888628000889
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 05/01/2020
• Device Model Number: 168-510
• Device Catalogue Number: 168-510
• Device Lot Number: 2920542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/19/2020
• 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
• Patient Age: 48 YR