MAUDE Adverse Event Report: Allergan (Costa Rica) Natrelle TE Smooth 133S-MV-13-T; expander, skin, inflatable

Catalog Number	133S-MV-13-T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "she felt heat and felt the expander move so the mri was aborted.She subsequently developed worsening mastectomy flap necrosis requiring explant of the tissue expander".This record is for the left side.The device was explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Additional, changed, and/or corrected data: a.2., d.1., d.4., d.6a., d.6b., h.4., h.11.

• Brand Name: Natrelle TE Smooth 133S-MV-13-T
• Common Device Name: expander, skin, inflatable
• 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 ; +1(847)936-6324
• MDR Report Key: 50599301
• Report Number: 9617229-2026-16879
• Device Sequence Number: 13278937
• Product Code: LCJ
• UDI-Device Identifier: 10888628043879
• UDI-Public: (01)10888628043879(17)300806
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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 Catalogue Number: 133S-MV-13-T
• Device Lot Number: 1341749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 09/06/2025
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 160 LB
• Patient Race: White