BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEELCHAIR COMPONENTS

    MDR report key: 3233317 · Received July 18, 2013

    Report

    Report Number
    9616091-2013-01241
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    UNKNOWN
    Product Code
    KNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 9616091-2013-01241 INDICTING THE BRAND NAME AS A MECHANICAL (MANUAL) WHEELCHAIR WITH COMMON DEVICE NAME AS 890.3850, MANUFACTURER AS INVAMEX AND THE FDA REGISTRATION NUMBER AS (B)(4) FOR INVAMEX. THE CORRECT BRAND NAME IS WHEELCHAIR COMPONENTS, CORRECT COMMON DEVICE NAME IS 890.3920, CORRECT MANUFACTURER IS UNKNOWN AND THE CORRECT FDA REGISTRATION NUMBER IS (B)(4), FOR DISTRIBUTED PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER STATES THE LEFT LEGREST PISTON IS JAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335917 WHEELCHAIR COMPONENTS 890.3920 KNN UNKNOWN T94HC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other