BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 10167118 · Received June 18, 2020

    Report

    Report Number
    10167118
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 12, 2020
    Report Date
    May 29, 2020
    Manufacturer
    SEMPERMED USA, INC.
    Product Code
    OPJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STARMED ULTRA NITRILE L GLOVE WAS RIPPED FROM WRIST TO FINGER OPENING OF 4TH AND 5TH FINGER. DEFECTIVE GLOVE AND ASSOCIATED BOX OF GLOVES AVAILABLE FOR RETURN TO MANUFACTURER. MANUFACTURER RESPONSE FOR HEALTHCARE GLOVES, STARMED ULTRA NITRILE L (PER SITE REPORTER). WAITING ON FEEDBACK FROM MANUFACTURER IF REQUEST DEFECTIVE PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632426 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES WITH CHEMOTHERAPY OPJ SEMPERMED USA, INC. SMTN254 2020-01 L052000 2001

    Patients

    Seq Age Sex Outcome Treatment
    1