BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGEL PI ULTRATOUCH

    MDR report key: 18190860 · Received November 22, 2023

    Report

    Report Number
    18190860
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    November 16, 2023
    Report Date
    November 17, 2023
    Manufacturer
    MOLNLYCKE HEALTH CARE US LLC
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON [REDACTED DATE], A PHYSICIAN RETRIEVED A PACKAGE OF STERILE NON-LATEX GLOVES. UPON OPENING THE GLOVES, HE NOTICED THAT THE INNER PAPER PACKAGE WAS LABELED AS LATEX GLOVES. THE GLOVE SUPPLY WAS SEARCHED IN THE CATH LAB AND ONE OTHER SIMILAR PACKAGE WAS FOUND. THE REST OF THE GLOVE SUPPLY ACROSS THE HOSPITAL WAS ALSO ASSESSED AND NO ADDITIONAL ABERRANT GLOVE WAS FOUND. OUR SUPPLY CHAIN LEADERS ARE REPORTING THIS INCIDENT TO THE MANUFACTURE. PRODUCT INFORMATION 23F4600, ¿LATEX FREE¿ PI ULTRATOUCH GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673626 BIOGEL PI ULTRATOUCH SURGEON'S GLOVES KGO MOLNLYCKE HEALTH CARE US LLC 23F4600

    Patients

    Seq Age Sex Outcome Treatment
    1 Male