BEUDAMED
    FDA Adverse Event Summary report: N

    CANES

    MDR report key: 2595187 · Received June 1, 2012

    Report

    Report Number
    1531186-2012-00346
    Date Received
    June 1, 2012
    Date of Event
    April 12, 2012
    Report Date
    May 31, 2012
    Manufacturer
    HL CORP. (SHENZHEN)
    Product Code
    IPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER IS A (B)(6) FEMALE. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE DEALER CALLED AND STATED THAT THE CONSUMER WAS ATTEMPTING TO TRANSFER FROM HER BED TO A RECLINER WHEN THE WELD AT THE BASE ALLEGEDLY BROKE, CAUSING THE CONSUMER TO FALL, SUFFERING BRUISING TO HER SHOULDER, HIP AND ARMS. MEDICAL INTERVENTION WAS SOUGHT. DEALER DOES NOT KNOW IF THE CONSUMER WAS GIVEN ANY MEDICATION. THE MAIN ROD OF THE CANE DID NOT BEND. IT IS UNKNOWN IF THE CONSUMER APPLIED HER TOTAL WEIGHT TO THE CANE AS SHE WAS GETTING UP. THE OWNER'S MANUAL STATES A WARNING ON PAGE 5, "THE CANE IS NOT DESIGNED TO SUPPORT THE TOTAL WEIGHT OF AN INDIVIDUAL". RMA (B)(4) HAS BEEN ISSUED AND THE PRODUCT IS TO BE RETURNED TO INVACARE FOR AN INSPECTION AND EVALUATION. THE DEALER HAS PROVIDED THE CONSUMER WITH A REPLACEMENT PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED WHEN STOOD UP TO TRANSFER FROM BED TO RECLINER, THE CANE BENT. ALSO STATED ALLEGEDLY IT LOOKS LIKE WELD MAY HAVE BROKE AT BOTTOM OF CANE. MINOR INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANES 890.3075 IPS HL CORP. (SHENZHEN) 3920

    Patients

    Seq Age Sex Outcome Treatment
    1 56 MO Other