MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MV-13-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MV-13-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a left side "tissue expander rupture" the device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's 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.
Event or Problem Description
Healthcare professional reported a left side "tissue expander deflation." healthcare professional additionally reported "discomfort" and "tissue expander implanted longer than 6 months." the device has been explanted and not replaced.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: deflation: observed, two openings anterior side assessed as surgical damage.Pain: unable to observe since it is not related to the device.Additional observations: creases are observed.No further actions are required since no issue in the manufacturing of the device is observed.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-13-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 15838720
• Report Number: 9617229-2022-20761
• Device Sequence Number: 6996630
• Product Code: LCJ
• UDI-Device Identifier: 10888628043879
• UDI-Public: 10888628043879
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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 Expiration Date: 02/19/2025
• Device Model Number: 133S-MV-13-T
• Device Catalogue Number: 133S-MV-13-T
• Device Lot Number: 3425921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 09/02/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2020
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 77 KG