BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1101543 · Received July 25, 2008

    Report

    Report Number
    1101543
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 25, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OHG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO PERFORMING A CIRCUMCISION ON AN INFANT, THE PHYSICIAN ASSEMBLED THE DEVICE TO CHECK FOR TIGHTNESS. THE BELL WAS LOOSE AFTER THE SCREW WAS TIGHTENED TO ITS FULLEST. ADDITIONALLY, THE "JAWS" OF THE HEMOSTAT DID NOT OPPOSE TIGHTLY WHEN IN THE LOCKED POSITION WITH A VISIBLE GAP NOTED AT THE TIP OF THE HEMOSTAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TRAY, CIRCUMCISION OHG MEDLINE INDUSTRIES, INC. DYNDF1044 08DB2039

    Patients

    Seq Age Sex Outcome Treatment
    1 *