BEUDAMED
    FDA Adverse Event Summary report: N

    WHEELCHAIR ACCESSORY

    MDR report key: 2940093 · Received February 1, 2013

    Report

    Report Number
    1531186-2013-00365
    Date Received
    February 1, 2013
    Report Date
    January 31, 2013
    Manufacturer
    NEW PROKIN
    Product Code
    INE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. FACILITY REPRESENTATIVE ALLEGED THAT WHERE THE HOOKS ARE, IT COMES DOWN AND THE STITCHING ON THE SLING RUBBED THE PATIENT'S SKIN. SHE STATED THE LINING OF THE STITCHING IS RUBBING THE PATIENTS SKIN. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44673 WHEELCHAIR ACCESSORY 890.3910 INE NEW PROKIN R114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other