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	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.
Event or Problem Description
Healthcare professional reported "fluid coming out" of device upon insertion and the device "was found with a tear in it." the device made contact with the patient.Surgery was completed with a back-up device.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified a broken shell, red particles, and flat creases.A leak test was performed and found a broken shell.A microscopic analysis identified a broken shell with striated edge on anterior side assessed as surgical damage.Fill inspection was performed and identified no blockage in the valve.Based on the device analysis the final assessment is: a broken shell with striated edge assessed as surgical damage.
Event or Problem Description
Healthcare professional reported "fluid coming out" of device upon insertion and the device "was found with a tear in it." the device made contact with the patient.Surgery was completed with a back-up device.

• 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: 7495264
• Report Number: 9617229-2018-03353
• Device Sequence Number: 1314715
• Product Code: FWM
• UDI-Device Identifier: 10888628000865
• UDI-Public: 10888628000865
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2020
• Device Catalogue Number: 168-450
• Device Lot Number: 3005761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/14/2018
• 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: 29 YR