BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 3853648 · Received April 3, 2014

    Report

    Report Number
    1036844-2014-00149
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 13, 2014
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    CAZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE, THE RESIDENT STUCK THEMSELVES WITH THE SAFETY SCALPEL IN THE KIT. THEY STATED THE SCALPEL FAILED TO LOCK. THE RESIDENT DID NOT REQUIRE ANY STITCHES OR BAND AIDS FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203493 UNK UNK CAZ ARROW INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1