BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGEL PI ULTRATOUCH G

    MDR report key: 11607152 · Received April 2, 2021

    Report

    Report Number
    11607152
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 25, 2021
    Report Date
    March 25, 2021
    Manufacturer
    MOLNLYCKE HEALTH CARE, US LLC
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TEAM MEMBERS AND PHYSICIANS COMPLAINING ABOUT GLOVES TEARING. PHYSICIAN REPORTED BLOOD BODY FLUID EXPOSURE FROM TORN GLOVE. THERE HAVE BEEN MULTIPLE VERBAL COMPLAINTS MADE ABOUT THESE GLOVES TEARING, ESPECIALLY WHEN DONNING THE GLOVES. GLOVES IN VARIOUS SIZES HAVE TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506674 BIOGEL PI ULTRATOUCH G SURGEON'S GLOVES KGO MOLNLYCKE HEALTH CARE, US LLC 42165

    Patients

    Seq Age Sex Outcome Treatment
    1