BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAINLESS STEEL SUTURE

    MDR report key: 451190 · Received April 2, 2003

    Report

    Report Number
    1221601-2003-00005
    Event Type
    Other
    Date Received
    April 2, 2003
    Date of Event
    October 1, 1997
    Report Date
    April 2, 2003
    Manufacturer
    GENZYME BIOSURGERY A DIVISION OF GENZYME
    Product Code
    GAQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT ALLEGED THEY HAD A HEART OPERATION IN 1997 AS A RESULT OF A HEART ATTACK. THE PT ALLEGES THEY WERE UNDER A DOCTOR'S CARE FROM 1997 THROUGH 2002 DUE TO PAIN IN CHEST, WHICH ORIGINALLY DIAGNOSED THE PAIN AS NORMAL POST-OPERATIVE PAIN. IN 2002, THE PT ALLEGEDLY HAD AN X-RAY TAKEN AND ALLEGES THERE WAS BROKEN STERNOTOMY WIRE IN THEIR CHEST. THE PT FURTHER ALLEGES THE BROKEN STERNOTOMY WIRE WAS THE CAUSE OF CHEST PAIN, AND TWO WEEKS FOLLOWING REMOVAL, THE PAIN ALLEGEDLY SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAINLESS STEEL SUTURE SUTURE GAQ GENZYME BIOSURGERY A DIVISION OF GENZYME UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other