BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEGAR UTERINE DILATOR, DOUBLE-ENDED, 7 1/2", SIZES

    MDR report key: 888830 · Received July 26, 2007

    Report

    Report Number
    2430952-2007-00018
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Report Date
    June 21, 2007
    Manufacturer
    UNK
    Product Code
    HDQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AN ADVERSE EVENT OR PRODUCT PROBLEM REPORT AND A REQUEST FOR INFORMATION WERE RECEIVED FROM FDA ON MAY 24, 2007. THE REPORT STATED: "WHILE PERFORMING A SUBTOTAL HYSTERECTOMY, THE PHYSICIAN NOTICED THAT A METAL POST WAS MISSING FROM THE HANK DILATOR. AN X-RAY OF THE PATIENT'S PELVIS WAS TAKEN; THERE WAS NO METAL POST SEEN BY THE RADIOLOGIST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEGAR UTERINE DILATOR, DOUBLE-ENDED, 7 1/2", SIZES SURGICAL INSTRUMENT HDQ UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *