BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 18873660 · Received March 11, 2024

    Report

    Report Number
    18873660
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    February 21, 2024
    Report Date
    February 23, 2024
    Manufacturer
    SEMPERMED USA, INC.
    Product Code
    OPJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GLOVE REMOVED FROM BOX. GLOVE APPEARED TO BE GLUED TOGETHER. MANUFACTURER RESPONSE FOR MEDICAL GLOVES, STAR MED ULTRA NITRILE GLOVE (PER SITE REPORTER). REPORTED TO SEMPER MED CUSTOMER SERVICE. EVENT REPORT AND PICTURES REPORTED TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695975 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES WITH CHEMOTHERAPY LABELING CLAIMS - TEST FOR USE WITH CHEMOTHERAP OPJ SEMPERMED USA, INC. SMTN253 L028264

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown