BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANK DILATOR

    MDR report key: 843532 · Received July 7, 2006

    Report

    Report Number
    843532
    Event Type
    Malfunction
    Date Received
    July 7, 2006
    Date of Event
    June 27, 2006
    Report Date
    July 7, 2006
    Manufacturer
    JARRET
    Product Code
    HDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    +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 HANK DILATOR DILATOR HDQ JARRET 500205 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR