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

Catalog Number	68-150
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
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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a right side "spontaneous ruptured implant one week." device remains implanted.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: opening, crease fold and wear abrasion.Leak test was performed and found opening on radius.A microscopic analysis was performed which identify a striated edge opening in the posterior side, consist with use of a surgical tool.The fill test inspection was performed, the result is no blockage.Based on the device analysis the final assessment is: a striated edge opening on posterior side due to surgical damage.
Event or Problem Description
Healthcare professional reported a right side "spontaneous ruptured implant one week." device has been explanted.

• 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; CS
• MDR Report Key: 8332195
• Report Number: 9617229-2019-00707
• Device Sequence Number: 11009495
• Product Code: FWM
• UDI-Device Identifier: 10888628000162
• UDI-Public: 10888628000162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2019

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: 01/21/2022
• Device Catalogue Number: 68-150
• Device Lot Number: 3169403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 02/21/2019; 03/21/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/18/2019; 04/12/2019
• 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