BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARA PLUS SLING

    MDR report key: 1970016 · Received January 21, 2011

    Report

    Report Number
    MW5019089
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    October 27, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ARJOHUNTLEIGH GETINGE GROUP
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MORBIDLY OBESE PT BEING TRANSFERRED WITH ASSISTANCE OF (B)(6) PT MOVER SYSTEM ON (B)(6)2010. THE LEFT, AND THEN THE RIGHT, STRAPS OF THE SLING TORE AWAY, REQUIRING STAFF TO LOWER THE PT TO THE FLOOR. THE PT WAS WITHIN THE WEIGHT LIMIT FOR THE SLING. PT COMPLAINED OF LEG AND FOOT PAIN POST INCIDENT. NO PERMANENT INJURIES TO THE PT. UPON INSPECTION, SEAMS ON EACH SIDE OF SLING HAD COMPLETELY COME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA PLUS SLING ARJO-SARA ACTIVE SLING FSA ARJOHUNTLEIGH GETINGE GROUP KKX52940-XL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR