BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGEL SURGEONS

    MDR report key: 10585797 · Received September 25, 2020

    Report

    Report Number
    10585797
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 23, 2020
    Manufacturer
    MOLNLYCKE HEALTH CARE, US LLC
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A PACKAGE OF BIOGEL GLOVES SIZE 6 1/2 WERE OPENED TO THE SURGICAL FIELD AND HAD 2 RIGHT HANDED GLOVES IN THE PACKAGING, NO LEFT HANDED GLOVE. NO PATIENTS OR STAFF WERE HARMED IN THE OPENING OF THESE GLOVES. WHEN THE ISSUE WAS NOTICED ANOTHER PAIR OF GLOVES WERE OPENED TO CONTINUE ON WITH THE SURGERY. IMAGE IS NOT THE PACKAGING FROM THIS EVENT AS IT WAS THROWN OUT AND THE CAREGIVER DID NOT RECORD WHAT THE LOT # WAS. PICTURE IS THE EXACT SAME PRODUCT SO IT CAN BE USED AS REFERENCE FOR THE PURPOSE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052141 BIOGEL SURGEONS NON-POWDERED SURGEON'S GLOVE KGO MOLNLYCKE HEALTH CARE, US LLC

    Patients

    Seq Age Sex Outcome Treatment
    1