BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOMA SCREW

    MDR report key: 115233 · Received August 21, 1997

    Report

    Report Number
    1418479-1997-00041
    Event Type
    Malfunction
    Date Received
    August 21, 1997
    Date of Event
    July 21, 1997
    Report Date
    July 22, 1997
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    HHO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A GYNECOLOGIC LAPAROSCOPY PROCEDURE TO REMOVE A MYOMA,THE HELICAL TIP OF THE MYOMA SCREW CAME OFF WHILE IT WAS IN THE MYOMA. THE TIP WAS RETRIEVED WITH NO CONSEQUENCES FOR THE PT. THE DEVICE WAS SENT TO THE MFR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOMA SCREW MYOMA SCREW HHO RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8383.611 4D3

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN