MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-FX-14-T; EXPANDER, SKIN, INFLATABLE

Catalog Number	133S-FX-14-T
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Dhr trend summary: the review of historical complaints on the complaint management handling system identified that there were other records for units manufactured on lot number 1254370: (b)(6): a020501 difficult to open or remove packaging material.Device not returned to device analysis.Even though there was 1 additional complaint of a020501 difficult to open or remove packaging material for this lot number, the device has not been returned to confirm the event or to detect a potential workmanship.The search criteria of these queries are mentioned on qpp07-01-004-her1-g02 (v6.0).The review of all potential trend evaluations for breast implants closed during the past 12 months indicates that no confirmed complaint trends have been observed for the event a020501 difficult to open or remove packaging material.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: tyvek or thermoform sticking.
Event or Problem Description
Healthcare professional reported "the inner box stuck and they had a very hard time getting the implant out".Device remains implanted.

• Brand Name: NATRELLE TE SMOOTH 133S-FX-14-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: 22333012
• Report Number: 9617229-2025-10580
• Device Sequence Number: 8994305
• Product Code: LCJ
• UDI-Device Identifier: 10888628044043
• UDI-Public: (01)10888628044043(10)1254370(11)240718(17)290618
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 133S-FX-14-T
• Device Lot Number: 1254370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/25/2025
• Date Device Manufactured: 07/18/2024
• 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: Unknown