BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCELERATOR-FREE NITRILE GLOVES

    MDR report key: 17653499 · Received August 29, 2023

    Report

    Report Number
    MW5145089
    Event Type
    Injury
    Date Received
    August 29, 2023
    Report Date
    August 25, 2023
    Manufacturer
    UNKNOWN
    Product Code
    LZA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO CUSTOMER SERVICE THAT THE CUSTOMER ORIGINALLY ORDERED THE FOLLOWING PRODUCT: ¿10-S203-0 SS NITRILE POWDER/ACCEL FREE GLOVE-MED¿. INSTEAD HE RECEIVED THIS PRODUCT SUB ¿10-F203-0 NITRILE POWDER FREE ACCEL FREE GLOVE MD¿. THE CUSTOMER STATED THAT THESE GLOVES ARE NOT ACCEPTABLE, THIS PRODUCT CAUSED TO THE NURSE RASHES ON HER HAND AND NEEDS FREE ACCELERATOR GLOVES. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603103 ACCELERATOR-FREE NITRILE GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown