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

Catalog Number	68-800
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional called, to report a unilateral left side deflation.Device remains implanted.
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.Reason for reoperation: deflation.
Event or Problem Description
The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data:a4, b5, d6b, h6.
Event or Problem Description
Healthcare professional called to report a unilateral left side deflation.The device has been explanted.
Event or Problem Description
Healthcare professional called to report a unilateral left side deflation.The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d.9., h.3., h.6 lab analysis summary: based on the device analysis grid, the assessments of the complaint are: deflation: observed, one opening assessed as unidentified (tear) opening (shell thickness within specification).As per the investigation procedure creases and wear abrasion were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.

• 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: terry ingram ; 2525 dupont drive; building 3; irvine, CA 92612 ; 8479366324
• MDR Report Key: 18097785
• Report Number: 9617229-2023-18086
• Device Sequence Number: 18115675
• Product Code: FWM
• UDI-Device Identifier: 10888628000346
• UDI-Public: 10888628000346
• 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
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/12/2024

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: 10/08/2025
• Device Catalogue Number: 68-800
• Device Lot Number: 3568171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 08/26/2024; 09/30/2024; 11/08/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 09/17/2024; 11/01/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 91 KG