BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIAVAC 400

    MDR report key: 18986 · Received August 31, 1994

    Report

    Report Number
    18986
    Event Type
    Other
    Date Received
    August 31, 1994
    Date of Event
    May 24, 1994
    Report Date
    July 5, 1994
    Manufacturer
    DAVOL INC.
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PRIOR TO USE ON PATIENT, 1/8" RELIAVAC DRAIN WAS FOUND TO BE DEFECTIVE. PRODUCT WAS NOT SAVED. PACKAGE WAS SAVED. SEE ATTACHED PACKAGE COVER (PHOTOCOPY). NO FURTHER INFORMATION IS AVAILABLE.(2 PACKAGES WERE INVOLVED.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIAVAC 400 CLOSED WOUND SUCTION KIT DAVOL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other