BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSPAN SYSTEM

    MDR report key: 726087 · Received June 8, 2006

    Report

    Report Number
    2210968-2006-00411
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    September 27, 2005
    Report Date
    February 20, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    FED
    PMA / PMN Number
    k961506
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION-THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. (510(K)#K961506)

    Description of Event or Problem · 1

    THE WHITE END CAME OFF WHEN ASSEMBELING SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSPAN SYSTEM SHEATH FED ETHICON, INC. NA 050324

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN