BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKET MEDICAL

    MDR report key: 853312 · Received May 18, 2007

    Report

    Report Number
    MW5001894
    Event Type
    Malfunction
    Date Received
    May 18, 2007
    Date of Event
    April 27, 2007
    Report Date
    February 21, 2006
    Manufacturer
    ROCKET MEDICAL
    Product Code
    MQF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ECHOGENIC BAND AT TIP OF CATHETER PARTIALLY DETACHED FROM CATHETER ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCKET MEDICAL EMBRYON ENDOCATH # R57630-EC-18 MQF ROCKET MEDICAL R57630-EL-18 409325

    Patients

    Seq Age Sex Outcome Treatment
    1 YR