BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSEC UMBILICAL CLAMP

    MDR report key: 299524 · Received October 4, 2000

    Report

    Report Number
    MW1020103
    Event Type
    Malfunction
    Date Received
    October 4, 2000
    Date of Event
    September 14, 2000
    Report Date
    October 4, 2000
    Manufacturer
    PROSEC PROTECTION SYSTEMS
    Product Code
    HFW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 1/12/01: ITEM #2: LETTER INDICATES THAT THE TEST DATA DOES NOT SUPPORT THE FACT THAT THE CLAMP WAS ATTRIBUTABLE TO THE ADVERSE EVENTS IN THE MEDICAL DEVICE REPORT. HOWEVER, UPON NOTIFICATION, PROSEC IMMEDIATELY REPLACED ALL OF THEIR STOCK WITH A DIFFERENT CLAMP. IN ADDITION, PROSEC IMMEDIATELY DISCONTINUED THE SALE AND DISTRIBUTION OF THE CLAMP IN QUESTION TO ANY HOSP.

    Description of Event or Problem · 1

    UMBILICAL CLAMP THAT HOUSES A SECURITY TRANSPONDER INADVERTENTLY CAME OFF INFANT, POTENTIALLY EXPOSING INFANT TO POSSIBLE ABDUCTION FROM NURSERY. MFR, PROSEC PROTECTION SYSTEMS, NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSEC UMBILICAL CLAMP INFANT UMBILICAL CLAMP W/ SECURITY TRANSPONDER DEVICE HFW PROSEC PROTECTION SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Other