BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLLISTER

    MDR report key: 289056 · Received August 1, 2000

    Report

    Report Number
    MW1019523
    Event Type
    Injury
    Date Received
    August 1, 2000
    Date of Event
    July 22, 2000
    Report Date
    July 31, 2000
    Manufacturer
    HOLLISTER, INC.
    Product Code
    HFW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/30/00: THE INVESTIGATION REVEALED THAT: THERE WAS NO INJURY INVOLVED IN THE REPORTED INCIDENT AND THE DEVICE INVOLVED WAS DISCARDED AND WAS NOT AVAILABLE FOR FURTHER TESTING OR INVESTIGATION. IN ADDITION THE INVESTIGATION REVEALED THAT THE LOT NUMBER OF THE DEVICE INVOLVED COULD NOT BE IDENTIFIED. THEREFORE, LOT SAMPLE TESTING COULD NOT BE PERFORMED. AS A RESULT OF THE INVESTIGATION AND THE FINDINGS DISCUSSED ABOVE, HOLLISTER CONSIDERS THIS FILE TO BE CLOSED.

    Description of Event or Problem · 1

    MOTHER OF NEWBORN NOTICED THAT UMBILICAL CLAMP WAS UNCLAMPED. SMALL AMOUNT OF BLEEDING NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLLISTER UMBILICAL CORD CLAMP HFW HOLLISTER, INC. CE 0050 *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Required Intervention