MAUDE Adverse Event Report: Allergan (Costa Rica) Natrelle TE Smooth 133S-FX-12-T; expander, skin, inflatable

Catalog Number	133S-FX-12-T
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional, through sales representative, reported "defect where it was stuck to itself".The device was not implanted.There was no patient involvement.
Event or Problem Description
Healthcare professional, through sales representative, reported "defect where it was stuck to itself".The device was not implanted.There was no patient involvement.
Additional Manufacturer Narrative
The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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.A review of the device history record has been completed.No deviations or non-conformances noted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b1, b2, d9, h1, h3, h6 device evaluation: per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: ¿ tyvek or thermoform sticking: not observed through visual inspection.None of the other observations performed during the device analysis intact are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.

• Brand Name: Natrelle TE Smooth 133S-FX-12-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: 50038374
• Report Number: 9617229-2026-14148
• Device Sequence Number: 18602895
• Product Code: LCJ
• UDI-Device Identifier: 10888628044029
• UDI-Public: (01)10888628044029(17)301215
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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-FX-12-T
• Device Lot Number: 1360037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2026
• 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