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

Model Number	168-480
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information contained in this report was previously submitted through asr on 29/jul/2016.A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: analysis of the returned device identified, opening on anterior.Leak test and microscopic analysis was performed which identified striated opening on anterior and broken sharp on plug strap.The fill test inspection was performed, the result is no blockage.Based on the device analysis the final assessment is; a striated opening assessed as surgical damage consist in the use of some surgical tool.A sharp opening on plug strap assessed as an unidentified (tear) opening.Wrinkling not observed.Reason for reoperation: deflation 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
Patient reported left side deflation.Device has been explanted.

• 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
• MDR Report Key: 11709124
• Report Number: 9617229-2021-01844
• Device Sequence Number: 3437846
• Product Code: FWM
• UDI-Device Identifier: 10888628000872
• UDI-Public: 10888628000872
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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: 09/10/2018
• Device Model Number: 168-480
• Device Catalogue Number: 168-480
• Device Lot Number: 2660726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/22/2021
• 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: 43 YR