BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGEL SKINSENSE NON-LATEX GLOVES

    MDR report key: 8277728 · Received January 24, 2019

    Report

    Report Number
    MW5083366
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Report Date
    January 21, 2019
    Manufacturer
    MOLNYLYCKE HEALTH CARE US LLC
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    GLOVES KEPT IN PYXIS BECAME DISCOLORED AND DEGRADED. MULTIPLES AFFECTED. PRODUCT NOT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65891 BIOGEL SKINSENSE NON-LATEX GLOVES SURGEONS' GLOVES KGO MOLNYLYCKE HEALTH CARE US LLC 16G362

    Patients

    Seq Age Sex Outcome Treatment
    1