BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIP-TIP URETHRAL SUTURE GUIDE

    MDR report key: 579816 · Received March 4, 2005

    Report

    Report Number
    MW1034866
    Event Type
    Malfunction
    Date Received
    March 4, 2005
    Date of Event
    March 3, 2005
    Report Date
    March 4, 2005
    Manufacturer
    GREENWALD SURGICAL CO, INC
    Product Code
    FBX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CO WOULD NOT PROVIDE TIME NOR TEMPERATURE FOR PRODUCT PURCHASED. THE DOCUMENT RECEIVED FROM THE CO ONLY STATES "STEAM AUTOCLAVING IS RECOMMENDED." NO PARAMETERS WERE GIVEN FOR AN INSTRUMENT THAT HAS A CHANNEL FOR RETRACTION OF PRONGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRIP-TIP URETHRAL SUTURE GUIDE URETHRAL SOUND WITH RETRACTABLE PRONGS FBX GREENWALD SURGICAL CO, INC U515 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other