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

Catalog Number	133S-MX-14-T
Medical Device Problem Codes	Break (1069); Malposition of Device (2616); Device Handling Problem (3265)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported expander got punctured after flipping.Later healthcare professional reported "flipped after placement".This record is for the left side.Device was explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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: broken device and use error.
Additional Manufacturer Narrative
Upon further review, abbvie medical safety determined that the event of device puncture/break is not related to the device.Hence unreporting the previously reported event of "break".Additional, changed, and/or corrected data: b5, h6.
Event or Problem Description
Upon further review, abbvie medical safety determined that the event of device puncture/break is not related to the device.Hence unreporting the previously reported event of "break".The event "flipped after placement" is serious and reportable.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-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: 22175003
• Report Number: 9617229-2025-09536
• Device Sequence Number: 7829553
• Product Code: LCJ
• UDI-Device Identifier: 10888628044203
• UDI-Public: (01)10888628044203(10)1255415(11)240730(17)290630
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 133S-MX-14-T
• Device Lot Number: 1255415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/09/2025
• Date Device Manufactured: 07/30/2024
• 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: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White