BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDCOMP

    MDR report key: 60318 · Received July 2, 1996

    Report

    Report Number
    60318
    Event Type
    Injury
    Date Received
    July 2, 1996
    Date of Event
    April 19, 1996
    Report Date
    May 1, 1996
    Manufacturer
    *
    Product Code
    FIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT DIALYZED FOR 2 HRS AND 45 MINS WHEN SHE DEVELOPED STOMACH CRAMPS. PT RINSED BACK AND WENT TO RESTROOM. VAGINAL BLEEDING NOTED. PT HAD HYSTERECTOMY 7 YEARS AGO. HCT DROPPED FROM 33 TO 25%. PT SENT TO HOSP. HEMOLYSIS IDENTIFIED. SHE WAS TRANSFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDCOMP Implant PERMACATH FIQ * UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R DIALYZER, NMC ARTERIAL REUSE LINE| FRESENIUS 2008H DIALYSIS MACHINE FRESENIUS F8