BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RICHARD-ALLAN MEDICAL

    MDR report key: 101796 · Received June 26, 1997

    Report

    Report Number
    101796
    Event Type
    Injury
    Date Received
    June 26, 1997
    Date of Event
    May 29, 1997
    Report Date
    June 9, 1997
    Manufacturer
    RICHARD-ALLAN MEDICAL
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RETURNED TO SURGERY WITHIN 24 HRS FOR POST-OP HEMORRHAGE. REQUIRING LIGATION OF UTERINE ARTERY. PT RECOVERED UNEVENTFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARD-ALLAN MEDICAL LAPAROSCOPIC STAPLING DEVICE GAG RICHARD-ALLAN MEDICAL REFLEX AEC 35 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| L| R BIPOLAR CAUTERY