BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE MEDICAL

    MDR report key: 1250464 · Received December 2, 2008

    Report

    Report Number
    2438477-2008-00011
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    September 5, 2008
    Report Date
    December 2, 2008
    Manufacturer
    NA
    Product Code
    INN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY MEDWATCH REPORT WAS FORWARDED TO DRIVE MEDICAL BY FDA. THE REPORT WAS SUBMITTED FOR A PRODUCT PROBLEM. IT WAS ALLEGED THAT ONE OF DRIVE'S SHOWER CHAIRS COLLAPSED WITH A PATIENT ON THE CHAIR. THE PATIENT WAS NOT INJURED. THE USER FACILITY REPORT DID NOT GIVE ANY INFORMATION ON THE PRODUCT, SUCH AS THE MODEL NUMBER, SERIAL NUMBER, NATURE OF EVENT, ETC.. WE ARE NOT ABLE TO DETERMINE THE DISTRIBUTOR AND MANUFACTURER OF THE SHOWER CHAIR. DRIVE MEDICAL HAS CONTACTED THE REPORTER VIA PHONE AND EMAIL TO REQUEST MORE INFORMATION ON THE PRODUCT AND EVENT. TWO PHOTOS HAVE BEEN RECEIVED FROM THE REPORTER SO FAR. BUT THE INFORMATION IS STILL INSUFFICIENT TO IDENTIFY THE PRODUCT AND THE CAUSE OF FAILURE. THIS MDR REPORT IS BASED ON THE USER FACILITY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL SHOWER CHAIR INN NA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR