BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPORT 20 IN X 16 IN 9153637574

    MDR report key: 5406428 · Received February 3, 2016

    Report

    Report Number
    9616091-2016-00152
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Report Date
    January 15, 2016
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THIS CHAIR HAS A DEFECT IN ONE OF THE HAND RIMS. - THE CUSTOMER SAID THE RIM IS PULLED APART AND IS NOT ABLE TO BE ADJUSTED TO FORM SMOOTH RIM FOR THE PATIENT TO PROPEL THE W/C--SEPARATED SILVER AREA IS EXTREMELY SHARP AND A RISK FOR DAMAGING THE PATIENT'S SKIN DURING USE. NO FURTHER INFO PROVIDED NO FOLLOW UP REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65460 TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1