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

Catalog Number	10-450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Nervous System Injury (2689); Skin Inflammation/ Irritation (4545)
Date of Event	10/12/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "moderate breast pain".Patient later reported "raynaud's phenomenon" that have been deemed not device related.Patient later reported "ulnar nerve damage, corpal and carpel tunnel damage right arm, elbow and wrist" and "red spots on my forearms and vulvar swelling appear then disappear, but the vulvar itching".This record is for the right side.Device was explanted and replaced and it is unknown if the device will be returned.
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/will be requested.No additional information is available at this time.The reason(s) for reoperation is/are: "ulnar nerve damage, corpal and carpel tunnel damage right arm, elbow and wrist" and "red spots on my forearms and vulvar swelling appear then disappear, but the vulvar itching".Information contained in this report was previously submitted through asr / psr on 2/3/2016.The reported events are physiological complications, and device analysis typically does not help allergan determine the cause.

• 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: 23960561
• Report Number: 9617229-2026-00174
• Device Sequence Number: 15821083
• Product Code: FTR
• UDI-Device Identifier: 10888628001299
• UDI-Public: 10888628001299
• 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: 2009
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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: 05/31/2014
• Device Catalogue Number: 10-450
• Device Lot Number: 1740371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/05/2026
• Date Device Manufactured: 07/06/2009
• 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: 51 YR
• Patient Sex: Female
• Patient Race: White