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

Catalog Number	68LP-420
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	09/30/2024
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.Reason for reoperation: capsular contracture, baker grade iii and deflation.
Event or Problem Description
Healthcare professional reported left side "patient has noticed a change in the size of implants, suspecting leak or deflation and capsular contracture, baker grade iii".Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b1, b5, d6b, h6.
Event or Problem Description
The device has been explanted and replaced.Observations made during surgery "any creases, possible leaking, particles in valve".
Event or Problem Description
Healthcare professional reported "patient has noticed a change in the size of implants, suspecting leak or deflation.Baker grade iii, capsular contracture".This record is for the left side.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d.9, h.3, h.6.Device evaluation: based on the product analysis performed, the assessments of the complaint codes are: deflation: observed 2openings assessed as surgical damage.Crease folding of implant: observed creases on the device.Particles in valve: not observed.Capsular contracture: unable to observe as it is not related to the device.As per the investigation procedure, wear abrasion were observed 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; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 20455105
• Report Number: 9617229-2024-22657
• Device Sequence Number: 8616210
• Product Code: FWM
• UDI-Device Identifier: 10888628000629
• UDI-Public: 10888628000629
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2010
• Device Catalogue Number: 68LP-420
• Device Lot Number: 1334169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 10/30/2024; 12/14/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/15/2024; 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2006
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White