BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 121545 · Received September 23, 1997

    Report

    Report Number
    2210968-1997-00297
    Event Type
    Injury
    Date Received
    September 23, 1997
    Date of Event
    June 19, 1997
    Report Date
    August 25, 1997
    Manufacturer
    ETHICON, INC.
    Product Code
    GCY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DRAIN BROKE. COMPLAINT WAS RECEIVED VIA MEDWATCH REFERENCE NUMBER 67728/1011799/. REPORT STATES THAT DRAIN BROKE WHICH REQUIRED A REOPERATION TO REMOVE. ETHICON INC'S INTERNAL CONTROL NUMBER IS 9700645-00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN Implant SURGICAL WOUND DRAIN GCY ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other