BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MVP

    MDR report key: 12952189 · Received December 7, 2021

    Report

    Report Number
    3005798905-2021-03024
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    October 20, 2021
    Report Date
    December 6, 2021
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    FMF
    PMA / PMN Number
    K102178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL TREND ANALYSIS AND PRODUCTION RECORDS FOR LOT 45011 FOR BOTH COMPLAINTS (B)(4) WERE ANALYZED, NO MALFUNCTIONS WERE FOUND. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    A MOBILE VET CLINIC REPORTS THAT 4 BOXES OF THE VET SYRINGES LOT 45011 EXP DATE 07/01/2022, ARE LEAKING VETSULIN MANUFACTURED BY (B)(4). THE LOCATION OF THE LEAK IS UNKNOWN BY THE REPORTER OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844346 MVP MVP VET SYRINGES FMF MHC MEDICAL PRODUCTS, LLC 45011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown