MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 20 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	20-550
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Cellulitis (1768); Unspecified Infection (1930)
Date of Event	01/01/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "breast infection, redness, aches, pain in the breast"."cellulitis/staph infection".Patient additionally reported "lupus, tired/sluggish, and "weight gain;" these events are not related to the device.Patient was admitted to an unknown hospital for three days and was treated with unknown intravenous medications.Later patient reported "rupture".This record is for the right side.The device remains implanted.
Additional Manufacturer Narrative
Information contained in this report was previously submitted through psr on 22/apr/2019.Clarification to b3: partial date of 2012 provided.A review of the device history record has been completed.No deviations or non-conformances noted.The events of cellulitis and infection are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been/will be requested.No additional information is available at this time.Reason for reoperation: cellulitis; infection; rupture.

• Brand Name: STYLE 20 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: 24443729
• Report Number: 9617229-2026-03587
• Device Sequence Number: 21423767
• Product Code: FTR
• UDI-Device Identifier: 10888628001756
• UDI-Public: 10888628001756
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2015
• Device Catalogue Number: 20-550
• Device Lot Number: 2008336
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/25/2026
• Date Device Manufactured: 09/03/2010
• 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: 34 YR
• Patient Sex: Female