BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERA SHEATH

    MDR report key: 192008 · Received October 14, 1998

    Report

    Report Number
    2951250-1998-00003
    Event Type
    Injury
    Date Received
    October 14, 1998
    Date of Event
    August 18, 1998
    Report Date
    September 1, 1998
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    FJL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    * CORRECT DATE OF THIS REPORT IS 10/1/1998. CORRECTION MADE ON 1/22/1999

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERA SHEATH RESECTOSCOPE SHEATH FJL CONCEPTUS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening| R