BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL

    MDR report key: 22674425 · Received July 31, 2025

    Report

    Report Number
    22674425
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 18, 2025
    Report Date
    July 22, 2025
    Manufacturer
    NEOMEND, INC.
    Product Code
    NBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GLASS VIAL CONTAINING PRODUCT CRACKED PRIOR TO APPLICATION, PRODUCT WAS DISCARDED, DID NOT REACH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56373 PROGEL SEALANT,POLYMERIZING NBE NEOMEND, INC. PGPS002 IRKQ0053

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female