BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYSTEROLUX HYSTEROSCOPIC INFLOW TUBE SET

    MDR report key: 15864221 · Received November 25, 2022

    Report

    Report Number
    3002914049-2022-00011
    Event Type
    Malfunction
    Date Received
    November 25, 2022
    Manufacturer
    W.O.M. WORLD OF MEDICINE GMBH
    Product Code
    HET
    UDI-DI
    04056702005795
    PMA / PMN Number
    K173489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: MFR REPORT # MW5112799: COVIDIEN HYSTEROLUX HYSTEROSCOPIC INFLOW TUBE SET- PACKAGING ARRIVED WITH NO LOT#, NO EXPIRATION DATE AND NO MANUFACTURE DATE LISTED. PRODUCT NOT USED AND RETURNED TO MANUFACTURER. ADDITIONAL INFORMATION PROVIDED BY THE DISTRIBUTOR: "08.11.2022 HS: FOR THIS ONE SINCE WE HAVE SUCH LIMITED INFORMATION, INCLUDING NO CONTACT INFORMATION, WE CANNOT SEND A REQUEST TO ANYONE ASKING FOR THE PRODUCT TO BE RETURNED. WE HAVE FILED IT UNDER (B)(4), PRODUCT:72205028, ITEM:10, LOT NO:UNKNOWN. FOR NOW, AFTER TALKING TO OUR PEOPLE, WE CAN CLOSE IT AS A NO SAMPLE AS WE ARE NOT EXPECTING TO GET THE PRODUCT BACK AT THIS TIME. IN THE OFF CHANCE THAT WE DO GET PRODUCT RETURNED THAT IS SOMEHOW TIED TO THE MEDWATCH OR THE PE WE CAN REOPEN THE COMPLAINT AND AMEND THE FILE AT THAT TIME. I HAVE CLOSED IT AS A NO SAMPLE TODAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686784 HYSTEROLUX HYSTEROSCOPIC INFLOW TUBE SET LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET W.O.M. WORLD OF MEDICINE GMBH ST261 04056702005795

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown