BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGEL SURGEON'S GLOVES

    MDR report key: 15319251 · Received August 30, 2022

    Report

    Report Number
    15319251
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Date of Event
    July 22, 2022
    Report Date
    August 25, 2022
    Manufacturer
    MOLNLYCKE HEALTH CARE US LLC
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BIOGEL STERILE SURGICAL GLOVES WERE BEING OPENED IN THE OR (OPERATING ROOM) FOR PROCEDURE AND A BUG WAS FOUND ON THE GLOVE THAT CAME FROM A CLOSED SEALED PACKAGE. BUG WAS FLATTENED AND APPEARED TO HAVE BEEN STERILIZED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274118 BIOGEL SURGEON'S GLOVES SURGEON'S GLOVES KGO MOLNLYCKE HEALTH CARE US LLC 30485 22A624

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown