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

Catalog Number	NON-ALLERGAN - BREAST
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare provider reported right side breast discomfort and intracapsular rupture via mri.The device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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.
Additional Manufacturer Narrative
It has been determined that the device is non-allergan and will be unreported.There is no complaint against an allergan device.
Event or Problem Description
It has been determined that the device is non-allergan and will be unreported.There is no complaint against an allergan device.

• Brand Name: NON-ALLERGAN
• 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): MANUFACTURER UNKNOWN; 900 parkway global park; zona franca; la aurora de heredia
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 19282015
• Report Number: 9617229-2024-08045
• Device Sequence Number: 12677436
• Product Code: FTR
• UDI-Device Identifier: 10888628001626
• UDI-Public: 10888628001626
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: -
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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: 09/06/2017
• Device Catalogue Number: NON-ALLERGAN - BREAST
• Device Lot Number: 2358327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2012
• 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: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White