BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANES

    MDR report key: 2082785 · Received April 29, 2011

    Report

    Report Number
    1525712-2011-00172
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 28, 2011
    Manufacturer
    HL CORP. (SHENZHEN)
    Product Code
    IPS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUSH BUTTON ALLEGEDLY POPPED OUT, CAUSING THE CANE TO COLLAPSE. THE CONSUMER ALLEGEDLY FELL AND SUSTAINED INJURY TO HER HIP AND FOOT. THE CONSUMER REPORTEDLY RECEIVED MEDICAL ATTENTION. PAST HISTORY WITH SIMILAR PRODUCTS INDICATES THAT USER INSTABILITY AND SUDDEN/IMPROPER DEVICE LOADING IS THE MOST LIKELY CAUSE OF THIS INCIDENT. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO, IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED ON ALLEGED MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    THE PUSH BUTTON ALLEGEDLY POPPED OUT, CAUSING THE CANE TO COLLAPSE. THE CONSUMER ALLEGEDLY FELL AND SUSTAINED INJURY TO HER HIP AND FOOT. NO SERIOUS INJURY IS ALLEGED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANES 890.3075 IPS HL CORP. (SHENZHEN) 8916 HL100111

    Patients

    Seq Age Sex Outcome Treatment
    1