MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) UNK MAMMARY IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	UNK MAMMARY IMPLANT
Medical Device Problem Codes	Material Rupture (1546); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1.Phone number continued: (b)(6).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.
Event or Problem Description
Healthcare professional reported right side "rupture".Patient undergone capsulectomy.The device has been explanted and replaced with non-abbvie device.
Additional Manufacturer Narrative
Clarification to d4 device information: the right-side device implanted following breast reconstruction in 2022 has been identified as a non-allergan/abbvie manufactured device.Sn (b)(6) noted in the initial medwatch was the patient's previous right-side device explanted on (b)(6) 2022.This record is no longer reportable to the fda and will be un-reported.Additional, changed, and/or corrected data: b2, b5, b6, b7, d1, d2a, d2b, d4, g4, h4, h6, h11.
Event or Problem Description
It has been determined that the device associated with this complaint is not manufactured by allergan/abbvie.This record is no longer reportable to the fda and will be un-reported.

• Brand Name: UNK MAMMARY IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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: 22022012
• Report Number: 9617229-2025-07933
• Device Sequence Number: 12956535
• Product Code: FWM
• UDI-Device Identifier: 10888628002333
• UDI-Public: (01)10888628002333(10)2887990(11)160322(17)210222
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2021
• Device Catalogue Number: UNK MAMMARY IMPLANT
• Device Lot Number: 2887990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/05/2025
• Date Device Manufactured: 03/22/2016
• 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 Sex: Female
• Patient Weight: 54 KG
• Patient Race: Asian