BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVACARE MEDICAL

    MDR report key: 2867997 · Received October 26, 2012

    Report

    Report Number
    3004766495-2012-00004
    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
    KS1203001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACEMENT WHEEL SENT ON WARRANTY REPLACEMENT ORDER # (B)(4). REWORK ALL INVENTORY PRODUCTS, REPLACE THE CASTER BROKE. (THROUGH INVESTIGATION, NO FINISHED GOODS). OPERATOR: (B)(4). FINISHED DATE: 06/22/2012. REWORK ALL SEMI-FINISHED PRODUCTS AT ASSEMBLY LINE. (THROUGH INVESTIGATION, NO SEMI-FINISHED PRODUCTS). OPERATOR: (B)(4). FINISHED DATE: 06/22/2012. REMARK AND ISOLATE THE RAW MATERIAL (FRONT CASTER), THEN NOTICE IQC CHECK AGAIN. DO DROP TESTING FOR 4 PCS SAMPLE, IF PASSED, THE RAW MATERIAL (FRONT CASTER) CAN BE USED. OPERATOR: (B)(4). FINISHED DATE: 06/22/2012. IPQC WILL INFORCE MONITORING THE PLASTIC INJECTION PARAMETERS. OPERATOR: (B)(4). FINISHED DATE: 06/25/2012.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES ONE OF THE CASTER WHEELS HAD SPLIT COMPLETELY THROUGH. REORDER (B)(4). NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE MEDICAL MECHANICAL (MANUAL) WHEELCHAIR IOR DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. V18RLR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other