BEUDAMED
    FDA Adverse Event Other Summary report: N

    8030916-2008-00009

    MDR report key: 1030076 · Received April 3, 2008

    Report

    Report Number
    8030916-2008-00009
    Event Type
    Other
    Date Received
    April 3, 2008
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO INFO GIVEN, THE LIFT IS IN GOOD WORKING CONDITION WITH EXCEPTION OF THE MISSING SAFETY LATCHES WHICH, BY USING OUR USERS GUIDE, DID NOT CONTRIBUTE TO THE EVENT BUT INDICATES THAT SERVICE OR MAINTENANCE IS NOT ACCORDING TO OUR INSTRUCTION. THE SLING USED IS NOT A RECOMMENDED COMBINATION WITH OUR PRODUCT AND WAS NOT MFG BY LIKO. DUE TO THIS, WE DO NOT KNOW WHAT GUIDELINES THIS SPECIFIC SLING MFR GAVE TO THE USER. SINCE THE LIFT IS IN GOOD WORKING CONDITION, NO CONCLUSIONS CAN BE MADE BY US REGARDING THE CAUSE OF THE EVENT. THIS INCIDENT COULD NOT BE RECREATED WHEN A LIKO SLING WAS USED WITH THE LIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FSA

    Patients

    Seq Age Sex Outcome Treatment
    1