BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD BINDER LIFT 2.0

    MDR report key: 23086847 · Received September 18, 2025

    Report

    Report Number
    3010001551-2025-00001
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 18, 2025
    Manufacturer
    BINDER LIFT INC., DBA PHASE
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER FOUND NO OTHER ISSUES IN THE SAME LOT. REPLACEMENT STRAPS WERE SHIPPED FOR THE AFFECTED DEVICE. BOTH THE CONTRACT MANUFACTURER AND PHASE INSPECTED ALL INVENTORY; NO FURTHER DEFECTS WERE IDENTIFIED. THE ISSUE WAS ISOLATED TO A SINGLE DEVICE.

    Description of Event or Problem · 0

    THE BINDER LIFT TRANSFER AID CONSISTS OF A TORSO WRAP WITH FULLY REMOVABLE LEG STRAPS. EACH LEG STRAP IS DESIGNED TO BUCKLE INTO BOTH THE FRONT AND BACK OF THE TORSO WRAP, WITH THE MALE BUCKLE ATTACHED TO THE LEG STRAP AND THE FEMALE BUCKLE ATTACHED TO THE TORSO WRAP. DURING USE OF A DEVICE FROM LOT NUMBER RFI-041625-S2 (UDI: (B)(4), PRODUCT CODE: S2-BL), ONE LEG STRAP MALFUNCTIONED BECAUSE THE STITCHING THAT ATTACHES THE STRAP TO ITS MALE BUCKLE WAS MISSING. WITHOUT THIS STITCHING, THE MALE BUCKLE DETACHED FROM THE STRAP AND COULD NOT PROPERLY CONNECT TO THE FEMALE BUCKLE ON THE TORSO WRAP. THE STRAP FAILURE WAS OBSERVED MID-USE, BUT THE TRANSFER LIFT ASSIST WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM OCCURRED, AND NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS WERE REPORTED. THE INCIDENT RESULTED IN NO HEALTH CONSEQUENCES OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2840328 STANDARD BINDER LIFT 2.0 BINDER LIFT 2.0 IKX BINDER LIFT INC., DBA PHASE S2-BL RFI-041625-S2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown