BEUDAMED
    FDA Adverse Event Summary report: N

    INVACARE MEDICAL

    MDR report key: 4635157 · Received March 18, 2015

    Report

    Report Number
    3004766495-2015-00050
    Date Received
    March 18, 2015
    Report Date
    March 16, 2015
    Manufacturer
    DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMED THE SUPPLIER, REQUEST SUPPLIER IMPROVE THEIR QUALITY OF PRODUCTIONS. RESPONSIBLE PERSON: (B)(4), DATE: 03/05/2015. TRAINING OUR ASSEMBLY WORKERS, REQUEST THEM SELF-CHECKING BEFORE ASSEMBLING. RESPONSIBLE PERSON: (B)(4), DATE: 03/06/2015. TRAINING OUR IPQC, PAY SPECIAL ATTENTION TO THE FRONT CASTER BEARINGS ON THE ASSEMBLY LINE. RESPONSIBLE PERSON: (B)(4), DATE: 03/06/2015.

    Description of Event or Problem · 1

    PROVIDER STATES THAT THE FRONT LEFT CASTER BOTH BEARINGS ARE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185961 INVACARE MEDICAL MECHANICAL (MANUAL) WHEELCHAIR IOR DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. V20RFR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other