BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED PLUS NITRILE EXAM GLOVES

    MDR report key: 20586832 · Received October 31, 2024

    Report

    Report Number
    MW5162012
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 28, 2024
    Report Date
    October 28, 2024
    Manufacturer
    SEMPERMED / HARPS INVESTMENT ASIA PTE., LTD.
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEFECTIVE GLOVES FROM MULTIPLE BOXES STARMED PLUS NITRILE LOT: L033135-2310, (B)(6). GLOVES ROUTINELY COME OUT WITH HOLES, DISCOLORED OR MELTED PLASTIC, TEARS, MISSING FINGERS. VENDOR REPORTS THE MANUFACTURER TOLD THEM THIS IS FROM TEARING OF THE GLOVES WHEN PULLED OUT OF BOX, THIS IS CLEARLY NOT THE CASE. GLOVES ARE MISSING LARGE PORTIONS OF NITRILE IN SOME CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91489 STARMED PLUS NITRILE EXAM GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA SEMPERMED / HARPS INVESTMENT ASIA PTE., LTD. L033135 2310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown