BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90-0322 VAGINAL DELIVERY TRACEPAK

    MDR report key: 365780 · Received December 7, 2001

    Report

    Report Number
    1057373-2001-00003
    Event Type
    Malfunction
    Date Received
    December 7, 2001
    Report Date
    December 3, 2001
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLOOD LEAKING FROM THE BOTTOM OF THE TRACECART NEAR THE WHEEL AREA. THE USER FACILITY CHECKED TO SEE IF THE LID WAS SEALED PROPERLY. THE TRACECART WAS REMOVED FROM THE HOSP AND DESTROYED. UNKNOWN TRACEPAK NUMBERS, HOWEVER, ALL USE THE SAME BASE. COMPLAINT FILED ON THE MOST USED TRACEPAK AT THIS HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55146 90-0322 VAGINAL DELIVERY TRACEPAK GCPDGROWTH CUST TRACEPAK LAB & DEL KDD DEROYAL INDUSTRIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other