BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMEX

    MDR report key: 206059 · Received January 12, 1999

    Report

    Report Number
    MW1015442
    Event Type
    Malfunction
    Date Received
    January 12, 1999
    Report Date
    December 30, 1998
    Manufacturer
    LUMEX MEDICAL PRODUCTS, INC.
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    RPTR WRITES: "LAST WEEK I DECIDED TO CONTACT LUMEX MED. PRODUCTS, INC. IN REGARD TO MY BATH CHAIR EXPERIENCE. I FOUND THEM POLITE AND AGREEABLE, AND THE GIRL IN CUSTOMER SVC UNDERSTOOD THE PROBLEM, THE BOTTOM OF THE CHAIR BREAKING AND EXPOSING SHARP EDGES OF PLASTIC WHICH WOULD BE HAZARDOUS. THE GIRL UNDERSTOOD WHAT I WAS TALKING ABOUT. I FEEL THAT THEY HAVE HAD OTHER SIMILAR COMPLAINTS. IT WAS AGREED THAT THEY WOULD SEND ME A NEW BOTTOM FOR THE CHAIR, AND THAT I WOULD PUT IT ON, AND AS I LATER FOUND OUT, THE LOCAL DEALER WOULD DO THIS FOR ME. SO TODAY I HAD DELIVERED TO ME NOT A BOTTOM, BUT TWO COMPLETE NEW CHAIRS. I DID NOT EXPECT THIS, OR DEMAND IT. INASMUCH AS THE CHAIRS ARE SILILAR TO THE ONE I HAVE, WITH THE SAME TYPE OF BOTTOM, I FEEL THAT IN TIME THE SAME PROBLEM WOULD ARISE, SO I WILL KEEP BOTH OF THEM, SO AS TO HAVE A SPARE. MY REASON FOR REPORTING THIS MATTER TO YOU WAS BECAUSE I FELT THAT A BATH CHAIR WAS BEING MARKETED TO SENIORS AND PTS WITH A POTENTIAL FOR HARM AND THAT THE MATTER SHOULD BE INVESTIGATED AND REMEDIES TAKEN. I WILL RETAIN THE DAMAGED SEAT AND COULD MAKE IT AVAILABLE TO THOSE INTERESTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX BATH CHAIR, WITH BACK. INM LUMEX MEDICAL PRODUCTS, INC. 7921 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other