MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-SX-15-T; EXPANDER, SKIN, INFLATABLE

Catalog Number	133S-SX-15-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: deflation.
Event or Problem Description
Healthcare professional reported unknown-side "expander that was leaking".Healthcare professional additionally reported "it was pin hole but i made it worse inspecting the area and squeezing to see where it was leaking from so the hole is bigger now".Device was explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ deflation and use error: observed, one opening assessed as surgical damage.As per the investigation procedure, crease missing on the suture tab were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.A review of the device history record has been completed.No deviations or non-conformances noted.Additional, changed, and/or corrected data: a2; b3; d1; d4; d9; g4; h3; h4; h6.
Event or Problem Description
Healthcare professional reported unknown-side "expander that was leaking".Healthcare professional additionally reported "it was pin hole but i made it worse inspecting the area and squeezing to see where it was leaking from so the hole is bigger now".Device was explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-SX-15-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 ; 8479366324
• MDR Report Key: 21550716
• Report Number: 9617229-2025-03924
• Device Sequence Number: 15495072
• Product Code: LCJ
• UDI-Device Identifier: 10888628043978
• UDI-Public: (01)10888628043978(10)3629723(11)220801(17)270701
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/07/2025

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 Catalogue Number: 133S-SX-15-T
• Device Lot Number: 3629723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: 39 YR
• Patient Sex: Female