BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEGAR DILATOR

    MDR report key: 1576052 · Received December 16, 2009

    Report

    Report Number
    1576052
    Event Type
    Malfunction
    Date Received
    December 16, 2009
    Date of Event
    December 7, 2009
    Report Date
    December 16, 2009
    Manufacturer
    CARDINAL HEALTH
    Product Code
    HDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    OUTPATIENT LAPAROSCOPY PERFORMED AT OUTPATIENT FACILITY. AFTER THE PROCEDURE, WHEN THE DILATOR THAT HAD BEEN USED IN THE CASE WAS BEING CLEANED, IT WAS NOTICED THAT IT HAD A CHIP OR HOLE IN THE TIP. AT THAT TIME THE PT HAD ALREADY BEEN DISCHARGED. HOWEVER, THE MD AND HIS PRACTICE RN FOLLOWED UP WITH THE PT AFTER BEING MADE AWARE OF EVENT. THE PT IS DOING VERY WELL AND DENIED ANY PAIN, ABDOMINAL DISTENTION, FEVER, BLEEDING, OR DISCHARGE. THE MD & CIRCULATING RN WERE OF THE OPINION THAT THE CHIP IN THE DILATOR WAS PRESENT PRIOR TO THE PROCEDURE (DUE TO A SMALL AMOUNT OF BLEEDING NOTED BY THE MD DURING THE PROCEDURE, WHICH WAS UNEXPECTED).MANUFACTURER RESPONSE (AS PER REPORTER) FOR DILATOR, HEGAR DILATOR:TO OUR SALES REPRESENTATIVE'S KNOWLEDGE THIS HAD NEVER OCCURRED BEFORE AND THEY WOULD LIKE TO CONDUCT TESTING FOR QA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEGAR DILATOR DILATOR HDQ CARDINAL HEALTH GL 1401-010 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR