BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLING, CLIP

    MDR report key: 7780695 · Received August 14, 2018

    Report

    Report Number
    3007420694-2018-00164
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Report Date
    July 23, 2018
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012068 BY THE ARJOHUNTLEIGH MAGOG INC. (REGISTRATION #9681684) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH INC (AHUS) (REGISTRATION #1419652). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSIONS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT DURING TRANSFERRING THE PATIENT USING THE CEILING LIFT ,THE SLING CRACKED AT LOOP LOCATION. PATIENT DID NOT FALL AND DID NOT SUSTAIN ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624901 SLING, CLIP LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other