BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAND SLING

    MDR report key: 2111002 · Received April 7, 2011

    Report

    Report Number
    9681684-2011-00023
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    DURING A TRANSFER FROM AN ACTIVE FLOOR LIFT, ONE OF THE SLING LOOPS BROKE. THE PT DID NOT FALL TO THE FLOOR BUT IT WAS REPORTED THAT THE CAREGIVER SUFFERED AN INJURY TO THEIR BACK AND WAS TAKEN TO EMERGENCY WHERE HE WAS KEPT FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAND SLING SLING FNG BHM MEDICAL, INC. TST-M

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization