MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 468 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	468-230
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/18/2019
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.The reason for reoperation is deflation.
Event or Problem Description
Healthcare professional reported a right-side "possible deflation." device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a4, b5, g1, h6.
Event or Problem Description
Healthcare professional reported a right side "possible deflation." healthcare professional later reported implant removal from textured to smooth due to the concerns of the product.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.
Event or Problem Description
Healthcare professional reported "fear alcl." device has been explanted and replaced.
Event or Problem Description
Healthcare professional reported a right-side "possible deflation." healthcare professional later reported removal from textured to smooth due to concerns of the product.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaints are: anxiety-product-procedure: unable to observe since it is not related to the device.Deflation: not observed.As per the investigation procedure was completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.Additional, changed, and/or corrected data: d.9., h.2., h.3., h.6.

• Brand Name: STYLE 468 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; suite 100; irvine, CA 92612 ; 8479366324
• MDR Report Key: 8621519
• Report Number: 9617229-2019-03220
• Device Sequence Number: 10857917
• Product Code: FWM
• UDI-Device Identifier: 10888628001091
• UDI-Public: 10888628001091
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 11/18/2024

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: 12/19/2020
• Device Catalogue Number: 468-230
• Device Lot Number: 3009494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 08/26/2024; 10/07/2024; 11/14/2024
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 09/11/2024; 10/11/2024; 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2017
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 57 KG