BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGEL SURGEONS SZ 7.5

    MDR report key: 4121286 · Received September 22, 2014

    Report

    Report Number
    3004763499-2014-00016
    Event Type
    Injury
    Date Received
    September 22, 2014
    Date of Event
    July 26, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MOLNLYCKE HEALTHCARE
    Product Code
    KGO
    PMA / PMN Number
    K970924
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(4). RECEIVED E-MAIL FROM FACILITY STATING BREAKAGE IN 45 MINS OF USE. NO SAMPLE WAS COLLECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587540 BIOGEL SURGEONS SZ 7.5 SURGEONS GLOVE KGO MOLNLYCKE HEALTHCARE NA 14 B012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other