BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVID MEDICAL, INC

    MDR report key: 340858 · Received July 3, 2001

    Report

    Report Number
    340858
    Event Type
    Injury
    Date Received
    July 3, 2001
    Date of Event
    May 10, 2001
    Report Date
    June 1, 2001
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING OPEN HEART SURGERY PROCEDURE, PIECE OF PLASTIC WAS NOTED IN THE PERICARDIUM AND REMOVED. ORIGIN OF PLASTIC APPEARED TO BE PITCHER WHICH IS ENCLOSED IN THE HEART PACK AND USED TO CONTAIN STERILE WATER USED FOR RINSING DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30073 AVID MEDICAL, INC PITCHER FROM OPEN HEART SURGERY PACK. LRO AVID MEDICAL, INC. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R