BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL GLOVE BIOGEL SURGEONS SIZE

    MDR report key: 9853247 · Received March 19, 2020

    Report

    Report Number
    9853247
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    January 13, 2020
    Report Date
    February 13, 2020
    Manufacturer
    MOLNLYCKE HEALTH CARE US LLC
    Product Code
    KGO
    UDI-DI
    05060097930906
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MOLNLYCKE BIOGEL SURGEONS NATURAL RUBBER LATEX SURGICAL GLOVES, SIZE 8 1/2, REF 30485, EXP 08/28/2022, LOT 191671 - OPENED OUTER PACKAGE AND LONG DARK HAIR SEEN WITHIN THE PACKAGE. PACKAGING AND HAIR SAVED; NO PATIENT EXPOSURE; NO CONTAMINATION OF FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316549 SURGICAL GLOVE BIOGEL SURGEONS SIZE SURGEON'S GLOVES KGO MOLNLYCKE HEALTH CARE US LLC 30485 191671 05060097930906

    Patients

    Seq Age Sex Outcome Treatment
    1