BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK

    MDR report key: 281590 · Received June 13, 2000

    Report

    Report Number
    1221601-1999-00003
    Event Type
    Death
    Date Received
    June 13, 2000
    Date of Event
    June 15, 1999
    Report Date
    September 28, 1999
    Manufacturer
    GENZYME SURGICAL PRODUCTS CORP.
    Product Code
    GAO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MEDWATCH RECEIVED BY GENZYME SURGICAL PRODUCTS ALLEGES THAT SUTURE USED IN A TETRALOGY OF FALLOT CORRECTION BROKE POST-OP FOLLOWING AN EPISODE OF COUGHING FOLLOWED BY SUDDEN EXSANGUINATION FROM THE MEDIASTINAL CHEST TUBE. MEDWATCH FILED BY HOSP WITH THE FDA INDICATED THAT THE SUTURE WAS 6-0 PROLINE. 6-0 PROLINE IS NOT MFG BY GENZYME SURGICAL PRODUCTS. IN A TELEPHONE CONVERSATION WITH LOSS PREVENTION SPECIALIST ON 9/28/99, THEY STATED THAT THE DR HAD INDICATED THE USE OF 6-0 PROLINE. IN THEIR NOTES, THE OR NURSE INDICATED AT A LATER DATE THAT THE SUTURE WAS DEKNATEL'S SUTURE. AT THIS POINT CO IS UNABLE TO MAKE A DETERMINATION REGARDING IDENTIFICATION OF THE PRODUCT. CO HAS NOT BEEN ABLE TO OBTAIN A PRODUCT CODE OR LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SUTURE GAO GENZYME SURGICAL PRODUCTS CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Death