BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEMPERMED VELVET NITRILE EXAM GLOVE MD

    MDR report key: 23726758 · Received December 4, 2025

    Report

    Report Number
    MW5179954
    Event Type
    Injury
    Date Received
    December 4, 2025
    Report Date
    December 2, 2025
    Manufacturer
    HARPS INVESTMENT ASIA PTE. LTD.
    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

    BREAKOUT/ RASH. 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
    2864173 SEMPERMED VELVET NITRILE EXAM GLOVE MD POLYMER PATIENT EXAMINATION GLOVE LZA HARPS INVESTMENT ASIA PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown