BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE TE SMOOTH 133S-MV-13-T

    MDR report key: 24168416 · Received January 23, 2026

    Report

    Report Number
    9617229-2026-01526
    Event Type
    Injury
    Date Received
    January 23, 2026
    Report Date
    February 24, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    UDI-DI
    10888628043879
    PMA / PMN Number
    K182054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS DEFLATION WAS RECEIVED ON FEBRUARY 11, 2026, WITH LOT NUMBER 1241882. PER THE INVESTIGATION PROCEDURE, THE DEVICE IS ANALYZED THROUGH VISUAL INSPECTION MICROSCOPIC INSPECTION IF OPENINGS ARE OBSERVED AND A WEIGHT VERIFICATION (IF APPLICABLE). PER THE ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS AND ANY POTENTIAL MANUFACTURING ISSUE ARE DISPLAYED ALONG WITH ANY FURTHER ACTIONS REQUIRED: ¿ DEFLATION: OBSERVED AN OPENING THROUGH MICROSCOPIC INSPECTION ASSESSED AS UNIDENTIFIED (TEAR) OPENING. NO FURTHER ACTIONS ARE REQUIRED AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. NO ADDITIONAL OBSERVATIONS PERFORMED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "TISSUE EXPANDER WAS DEFLATED UPON REMOVAL". THIS RECORD IS FOR AN UNKNOWN SIDE. THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "TISSUE EXPANDER WAS DEFLATED UPON REMOVAL". THIS RECORD IS FOR AN UNKNOWN SIDE. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224314 NATRELLE TE SMOOTH 133S-MV-13-T EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) 1241882 10888628043879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention