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

Catalog Number	133S-MX-15-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported right side "deflation".Device has been 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: deflation.
Additional Manufacturer Narrative
Lab analysis: based on the device analysis grid, the assessments of the complaint are: ¿ deflation: observed two openings assessed as surgical damage.¿ difficulty with fill tube: not observed.As per the investigation procedures, observed total delamination and missing of 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.
Event or Problem Description
Healthcare professional reported ¿lower central tab completely pulled off + free floating on breast pocket¿, "hole, non-specific", "tab was ripped off".

• Brand Name: NATRELLE TE SMOOTH 133S-MX-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: 21845534
• Report Number: 9617229-2025-06231
• Device Sequence Number: 9253617
• Product Code: LCJ
• UDI-Device Identifier: 10888628044210
• UDI-Public: (01)10888628044210(10)1260872(11)240828(17)290728
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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-MX-15-T
• Device Lot Number: 1260872
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White