BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGEL SURGEONS GLOVE

    MDR report key: 8277443 · Received January 25, 2019

    Report

    Report Number
    8277443
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    December 24, 2018
    Report Date
    December 28, 2018
    Manufacturer
    MOLNLYCKE HEALTH CARE US LLC
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HAIR WAS FOUND IN A PAIR OF 7.5 LATEX BIOGEL STERILE GLOVES PRIOR TO INCISION. GLOVES WERE DISCARDED AND A NEW PAIR WAS OPENED TO THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72876 BIOGEL SURGEONS GLOVE SURGEON'S GLOVES KGO MOLNLYCKE HEALTH CARE US LLC (10)18I638

    Patients

    Seq Age Sex Outcome Treatment
    1