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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/06/2024
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 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 a050401 - fluid/blood leak.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: device deflation.
Event or Problem Description
Healthcare professional reported "noticed a small hole, looks like it separated from the seam".Later healthcare professional reported "tissue expander deflated spontaneously during post-operative period after being inflated in operating room at time of surgery".This record is for the left side side.Device was explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d9, h3, h6.Device evaluation: based on the device analysis grid, the assessments of the complaint are: deflation: observed, one opening assessed as unidentified (tear) opening.As per the investigation procedure, crease and wear abrasion 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 "noticed a small hole, looks like it separated from the seam".Later healthcare professional reported "tissue expander deflated spontaneously during post-operative period after being inflated in operating room at time of surgery".This record is for the left side.Device was explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: e1, e2, e3.
Event or Problem Description
Healthcare professional reported "noticed a small hole, looks like it separated from the seam".Later healthcare professional reported "tissue expander deflated spontaneously during post-operative period after being inflated in operating room at time of surgery".This record is for the left side side.Device was explanted and replaced.

• 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 ; 8479366324
• MDR Report Key: 22015268
• Report Number: 9617229-2025-07848
• Device Sequence Number: 9530391
• Product Code: LCJ
• UDI-Device Identifier: 10888628044180
• UDI-Public: (01)10888628044180(10)3645668(11)221011(17)270911
• 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
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2025

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-12-T
• Device Lot Number: 3645668
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 05/30/2025; 07/11/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/27/2025; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic