BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBITEX V200 SERIES VINYL EXAM GLOVES

    MDR report key: 11738074 · Received April 27, 2021

    Report

    Report Number
    MW5101050
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Report Date
    April 27, 2021
    Manufacturer
    TRADEX INTERNATIONAL, INC. / CARDINAL HEALTH 200, LLC
    Product Code
    LYZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT STATES THAT AFTER OPENING THE BOX OF AMBITEX V200 SERIES VINYL EXAM GLOVES AND TAKING ONE GLOVE OUT, HE NOTICED AT A CONTAMINATION INSIDE. PT REPORTS THAT AT THE END OF THE EXAM GLOVE TOWARDS THE ROLLED UP FABRIC AT THE WRIST AREA, THERE WAS A BIG BLACK CLUMP OF FOREIGN MATERIAL ROLLED INTO THE GLOVE. PT STATES THIS CONTAMINATION SEEMS TO BE FROM PRODUCTION. PT ALSO NOTES THAT NO HE ONLY NOTICED CONTAMINATION ON SINGULAR GLOVE BUT DID NOT EXAMINE THE REST FROM THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626716 AMBITEX V200 SERIES VINYL EXAM GLOVES VINYL PATIENT EXAMINATION GLOVE LYZ TRADEX INTERNATIONAL, INC. / CARDINAL HEALTH 200, LLC VXL200 T412200601

    Patients

    Seq Age Sex Outcome Treatment
    1