BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIMBA SPRING STROLLER

    MDR report key: 2022322 · Received March 14, 2011

    Report

    Report Number
    MW5019815
    Event Type
    Death
    Date Received
    March 14, 2011
    Date of Event
    September 2, 2010
    Report Date
    March 14, 2011
    Manufacturer
    OTTO BOCK HEALTHCARE, GMBH
    Product Code
    INM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING IS A REPORT OTTO BOCK HEALTHCARE RECEIVED FROM THE ATTORNEY HIRED BY THE PT'S MOTHER AND FATHER: A (B)(6) WITH CEREBRAL PALSY WAS WATCHING TV WHILE FULLY STRAPPED INTO THE KIMBA SPRING STROLLER IN THE UPRIGHT POSITION. HER MOTHER CHECKED ON HER FROM TIME TO TIME TO MAKE SURE SHE WAS OK. THE GIRL APPARENTLY MOVE HER BODY AROUND IN THE STROLLER AND THE STRAPS ON HER CHEST AND PELVIC BELT LOOSENED. SHE THEN SLIPPED FORWARD, ENOUGH TO CAUSE ONE OF THE STRAPS TO PUT PRESSURE ON THE NECK. HER SISTER FOUND HER WITH THE PELVIC STRAP AROUND HER NECK. SHE WAS TAKEN TO THE HOSPITAL AND PASSED AWAY ONE WEEK LATER. OTTO BOCK HEALTHCARE FIRST RECEIVED A MEMORANDUM FROM THE PT'S ATTORNEY NOTIFYING US OF THIS INCIDENT ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBA SPRING STROLLER ADAPTIVE STROLLER INM OTTO BOCK HEALTHCARE, GMBH 3291

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death