BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD-ALLAN

    MDR report key: 77634 · Received March 12, 1997

    Report

    Report Number
    77634
    Event Type
    Malfunction
    Date Received
    March 12, 1997
    Date of Event
    January 8, 1997
    Report Date
    January 10, 1997
    Manufacturer
    RICHARD-ALLAN MEDICAL
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TO OR FOR VAGINAL HYSTERECTOMY AND BLADDER NECK SUSPENSION. THE EYE OF THE NEEDLE BROKE OFF INTO THE OPERATIVE FIELD AND LODGED IN THE TISSUE. X-RAY CONFIRMED AND DECISION WAS MADE TO LEAVE THE TINY METALLIC FRAGMENT IN THE PT ADJACENT TO THE LEFT PUBIC BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARD-ALLAN MAYO 1/2 TROCAR GAB RICHARD-ALLAN MEDICAL 217005 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other