BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHA MODALITIES SINGLE PATIENT USE SLING SIZE XL

    MDR report key: 12280867 · Received August 4, 2021

    Report

    Report Number
    MW5103025
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 12, 2021
    Report Date
    August 3, 2021
    Manufacturer
    ALPHA MODALITIES LLC
    Product Code
    INE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEW CEILING LIFT SLING WAS OPENED AND PLACED UNDER PATIENT. WHILE RAISING THE PATIENT USING THE CEILING LIFT, THERE WAS A RIPPING SOUND AND THE SLING WAS RIPPING APART. THE PATIENT WAS DESCENDED BACK DOWN WITH NO INJURY. SLING IS RATED TO SUPPORT 800 LB, PATIENT WEIGHED LESS THAN 300 LBS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169490 ALPHA MODALITIES SINGLE PATIENT USE SLING SIZE XL SLING, OVERHEAD SUSPENSION, WHEELCHAIR INE ALPHA MODALITIES LLC

    Patients

    Seq Age Sex Outcome Treatment
    1