BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 12335851 · Received August 18, 2021

    Report

    Report Number
    12335851
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 28, 2021
    Report Date
    August 5, 2021
    Manufacturer
    SEMPERMED USA, INC.
    Product Code
    OPJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE STARMED ULTRA NITRILE EXAM GLOVES WERE REMOVED FROM BOX, IT WAS EVIDENT THAT THEY WERE ¿RIPPED¿ IN BOX- PRIOR TO REMOVAL. TWO SEPARATE EVENTS. (1) A GLOVE WAS REMOVED FROM THE BOX AND WAS RIPPED FROM THE WRIST ALL THE WAY THROUGH THE THUMB. MFG DATE/LOT# 2021-01 L074702 2101 SIZE LARGE. THE BOX WAS RETAINED. (2) BOX OF MEDIUM STARMED NITRILE GLOVES, THE FIRST GLOVE WAS FOUND TO BE BADLY RIPPED AND UNUSABLE. THIS ISSUE HAS BEEN A RECURRENT PROBLEM RECENTLY. OUR CENTER'S GLOVE SPEND HAS DRASTICALLY INCREASED THIS YEAR AND STAFF REPORT IT IS DUE TO HIGH NUMBERS OF UNUSABLE GLOVES. MFG ITEM NUMBER SMTN253. DATE AND LOT # 2021-02 L076327 2102(NOT SAVED). SEMPERMED USA, INC. WILL LOOK INTO THE RECURRENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235806 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES W/ CHEMOTHERAPY LABELING CLAIMS - FOR USE W/ CHEMOTHERAPY DRUGS OPJ SEMPERMED USA, INC. L074702

    Patients

    Seq Age Sex Outcome Treatment
    1