BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFTING POLE & HANDLE ASSAY

    MDR report key: 1981085 · Received January 28, 2011

    Report

    Report Number
    3003984900-2011-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 15, 2009
    Report Date
    January 19, 2009
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A RETROSPECTIVE REVIEW OF RELATED REPORTS WAS CONDUCTED FOLLOWING (B)(4) RECALL NOTIFICATION TO (B)(4). THIS EVENT WAS DETERMINED TO BE REPORTABLE. ADDITIONALLY, (B)(4) INITIATED A RECALL IN (B)(4) 2011.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT IN 2009 FROM OUR (B)(4) SUBSIDIARY THAT A STRAP AND HANDLE ACCESSORY MANUFACTURED BY (B)(4) HAD BROKEN WHILE A PT WAS LIFTING HIMSELF USING THE HANDLE. SINCE THAT TIME, THE MANUFACTURER HAS WRITTEN TO OUR COMPANY TO INFORM US OF SIMILAR INCIDENTS WITH THEIR PRODUCT. THE ACCESSORY INVOLVED IN THE EVENT IN (B)(6) WAS OUR PART NUMBER MB ACC34, WHICH IS NOT SOLD IN USA. HOWEVER, IT IS SIMILAR TO A PRODUCT THAT WE DISTRIBUTE IN THE USA (ENT-ACC01 LIFTING POLE & HANDLE). IT WAS REPORTED THAT AS THE PT WAS APPLYING HIS WEIGHT TO THE HANDLE, THE RETRACTOR HOUSING FOR THE STRAP BROKE AND THE HANDLE STUCK THE PT IN THE FACE. THE LENS FROM THE PT'S GLASSES STRUCK HIS EYE, BUT NO INJURY WAS SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFTING POLE & HANDLE ASSAY BED ACCESSORY FNL ARJOHUNTLEIGH MB-ACC34

    Patients

    Seq Age Sex Outcome Treatment
    1 Other