BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADHESIVE REMOVER SPRAY

    MDR report key: 21071385 · Received January 2, 2025

    Report

    Report Number
    MW5164263
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 30, 2024
    Report Date
    December 31, 2024
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CONVATEC INC. ADHESIVE REMOVER SPRAY, WITH VERY OFFENSIVE ODOR AND UNABLE TO BE USED ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949463 ADHESIVE REMOVER SPRAY PROTECTOR, OSTOMY EXE CONVATEC, INC. 9259917

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Prefer Not To Disclose Other