BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLOK EXTRA ABSORBABLE LIGATING CLIPS

    MDR report key: 158795 · Received March 20, 1998

    Report

    Report Number
    1527736-1998-00817
    Event Type
    Malfunction
    Date Received
    March 20, 1998
    Report Date
    February 20, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE AP400 WAS USED DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THERE WAS POST OPERATIVE BLEEDING FROM LIGATURE OF THE GEA. THERE WAS AN EXTENDED HOSPITAL STAY OF UNK LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLOK EXTRA ABSORBABLE LIGATING CLIPS LIGATION FZP ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other