BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON/MODIFIED TRINKLE ATTACH

    MDR report key: 3760749 · Received April 21, 2014

    Report

    Report Number
    0001811755-2014-01396
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION HAS BEEN COMPLETED. NOT YET RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION, SO THE REPORTED EVENT, LEAKING, COULD NOT BE CONFIRMED IN THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HUDSON/MODIFIED TRINKLE ATTACHMENT WAS OBSERVED TO LEAK A RED SUBSTANCE DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HUDSON/MODIFIED TRINKLE ATTACHMENT WAS OBSERVED TO LEAK A RED SUBSTANCE DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239399 HUDSON/MODIFIED TRINKLE ATTACH INSTRUMENT, SURGICAL, ORTHOPED HWE STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1