BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBSTETRICAL VACUUM DELIVERY SYSTEM

    MDR report key: 243013 · Received August 4, 1999

    Report

    Report Number
    MW1017274
    Event Type
    Injury
    Date Received
    August 4, 1999
    Date of Event
    September 2, 1998
    Manufacturer
    HOLLISTER, INC.
    Product Code
    HDB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/2/00: HOLLISTER INC HAS REVIEWED THE VOLUNTARY MEDWATCH FORM NUMBER 1017274 AND HAS DETERMINED THAT REPORT NUMBER MW 1017274 DID NOT CONTAIN SUFFICIENT INFO REGARDING THE IDENTITY OF USER FACILITY OR MEDWATCH RPTR TO CONDUCT AN INVESTIGATION. HOLLISTER INC CONSIDERS THIS REPORT TO BE CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBSTETRICAL VACUUM DELIVERY SYSTEM VACUUM EXTRACTION DEVICE HDB HOLLISTER, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| L| R| S