BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBI SLING

    MDR report key: 1993138 · Received February 11, 2011

    Report

    Report Number
    9681684-2011-00012
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNCLEAR AT THIS TIME IF THE SLING WAS USED WITH A BHM MEDICAL LIFT. FURTHER INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE CLIENT WAS BEING LOWERED ONTO THE CHAIR, AND ONE OF THE LEG STRAPS BROKE. HE WAS NOT HARMED DURING THIS INCIDENT, JUST A LITTLE STARTLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBI SLING SLING FSA BHM MEDICAL, INC. 626002M

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other