BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATRELLE 133S TISSUE EXPANDERS

    MDR report key: 23108395 · Received September 22, 2025

    Report

    Report Number
    23108395
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    December 5, 2024
    Report Date
    September 16, 2025
    Manufacturer
    ALLERGAN, INC.
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PT UNDERWENT A L [LEFT] MASTECTOMY WITH L RE [RECONSTRUCTION] PLACEMENT. PROCEDURE WAS UNEVENTFUL. ON THE 6TH OFFICE VISIT POST-PROCEDURE THE SURGEON IDENTIFIED LAXITY OF THE SKIN, AND THE EXPANDER WAS NOT FIRM. THE SURGEON ATTEMPTED TO FILL THE EXPANDER AND NOTED THE IMPLANT DID NOT HOLD THE CC'S. PT. UNDERWENT A REPLACEMENT TISSUE EXPANDER PROCEDURE 4 DAYS LATER AND NOTED A SMALL PUNCTURE IN THE EXPANDER ADJACENT TO THE INFEROMEDIAL TAB.

    Description of Event or Problem · 0

    PT UNDERWENT A L [LEFT] MASTECTOMY WITH L RE [RECONSTRUCTION] PLACEMENT. PROCEDURE WAS UNEVENTFUL. ON THE 6TH OFFICE VISIT POST-PROCEDURE THE SURGEON IDENTIFIED LAXITY OF THE SKIN, AND THE EXPANDER WAS NOT FIRM. THE SURGEON ATTEMPTED TO FILL THE EXPANDER AND NOTED THE IMPLANT DID NOT HOLD THE CC'S. PT. UNDERWENT A REPLACEMENT TISSUE EXPANDER PROCEDURE 4 DAYS LATER AND NOTED A SMALL PUNCTURE IN THE EXPANDER ADJACENT TO THE INFEROMEDIAL TAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2655279 NATRELLE 133S TISSUE EXPANDERS EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN, INC. 133S-FV-12-T

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Other