MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 10 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	10-390
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported via sus voluntary event report "breast pain and sensitivity, energy level way down, lack of sleep, major hair loss, bloated, psoriatic arthritis, memory issues, foggy brain, can't focus, dry eyes, light sensitivity, libido way down, rashes once in a while, can't sleep on my stomach anymore, breast is sore and burning sensation, ruptured device, had capsulectomy, daily minimum tasks are becoming more and more difficult, have extreme fatigue, and back pain on top of it all".The events of ¿back pain on top of it all,¿ ¿psoriatic arthritis,¿ ¿dry eyes,¿ "have extreme fatigue,¿ ¿energy level way down, lack of sleep major hair loss, bloated, memory issues, foggy brain, light sensitivity, libido way down, can't sleep on my stomach anymore¿ have been deemed not related to the device.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a6, b5, g2, h.10.
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: rupture.
Event or Problem Description
Patient reported, right side "having symptoms of bii for a few years"."had a mammogram and it was proven the implant is ruptured" and "recalled".The event of "having symptoms of bii for a few years", has been deemed not related to the device.Device remains implanted.

• Brand Name: STYLE 10 SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 20802793
• Report Number: 9617229-2024-25210
• Device Sequence Number: 13247127
• Product Code: FTR
• UDI-Device Identifier: 10888628001275
• UDI-Public: 10888628001275
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2013
• Device Catalogue Number: 10-390
• Device Lot Number: 1645157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2008
• 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: 84 KG
• Patient Ethnicity: Hispanic
• Patient Race: White