BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVACARE MEDICAL

    MDR report key: 2867973 · Received October 26, 2012

    Report

    Report Number
    3004766495-2012-00006
    Event Type
    Other
    Date Received
    October 26, 2012
    Date of Event
    February 8, 2012
    Report Date
    October 23, 2012
    Manufacturer
    DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.
    Product Code
    IOR
    Removal / Correction Number
    KS1205001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REWORK ALL INVENTORY PRODUCTS, REPLACE THE REAR TIRE ALLEGEDLY CAME OFF THE CHAIR. (THROUGH REWORK, NO FOUND BAD PRODUCT). OPERATOR: (B)(4). FINISHED DATE: 06/21/2012. REWORK ALL SEMI-FINISHED PRODUCTS AT ASSEMBLY LINE. (THROUGH REWORK, NO FOUND BAD PRODUCT). OPERATOR: (B)(4). FINISHED DATE: 06/21/2012. REMARK AND ISOLATE THE RAW MATERIAL (REAR TIRE ALLEGEDLY), THEN NOTICE IQC CHECK AGAIN. DO COME OFF TEST FOR 4 PCS SAMPLE, IF PASSED, THE RAW MATERIAL (REAR TIRE ALLEGEDLY) CAN BE USED. OPERATOR: (B)(4). FINISHED DATE: 06/22/2012. MAKING COME OFF TEST DEVICES, MATERIAL OF EACH COME OFF TEST. OPERATOR: (B)(4). FINISHED DATE: 06/23/2012.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE BEARINGS INSIDE THE CASTERS WERE GOING OUT, NOT TURNING THE WHEEL PROPERLY. WARRANTY ORDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE MEDICAL MECHANICAL (MANUAL) WHEELCHAIR IOR DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. V18RFR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention