BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1081381 · Received July 6, 2008

    Report

    Report Number
    1081381
    Event Type
    Malfunction
    Date Received
    July 6, 2008
    Date of Event
    June 4, 2008
    Report Date
    July 6, 2008
    Manufacturer
    PHS CUSTOM PACKAGING
    Product Code
    OHG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    CURVED AND STRAIGHT HEMOSTATS FAILED TO HOLD DURING CIRCUMCISION OF INFANT RESULTING IN INCREASED BLEEDING AND DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PACK, CIRCUMCISION OHG PHS CUSTOM PACKAGING * 806840

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY