MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) Natrelle TE Smooth 133S-MX-12-T; expander, skin, inflatable

Catalog Number	133S-MX-12-T
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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: contamination.
Event or Problem Description
Healthcare professional, through sales representative, reported "a hair was in one of the products upon opening it".The device was not implanted.There was no patient involvement.
Event or Problem Description
Healthcare professional, through sales representative, reported "a hair was in one of the products upon opening it".The device was not implanted.There was no patient involvement.
Additional Manufacturer Narrative
Additional and/or corrected data: d9, h3, h6.Device evaluation: in accordance with the investigation procedure, the device underwent visual inspection, microscopic inspection (if openings were observed), and weight verification.Based on the analysis performed, the evaluations regarding the complaint and any potential manufacturing issues are presented below, along with the required follow-up actions: - hair/fiber on the implant: a fiber was observed on the implant during visual and microscopic inspection; this is not classified as a workmanship defect due to the device was received with its respective package open.Nevertheless, further investigation is requested.No additional observations performed on the device.No further actions are required.

• Brand Name: Natrelle TE Smooth 133S-MX-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: 25813146
• Report Number: 9617229-2026-13282
• Device Sequence Number: 17633491
• Product Code: LCJ
• UDI-Device Identifier: 10888628044180
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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-MX-12-T
• Device Lot Number: 1350747
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2025
• 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 Sex: Unknown