BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 175544 · Received June 29, 1998

    Report

    Report Number
    1221601-1998-00002
    Event Type
    Malfunction
    Date Received
    June 29, 1998
    Date of Event
    May 7, 1998
    Report Date
    June 24, 1998
    Manufacturer
    GENZYME SURGICAL PRODUCTS CORP.
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DOCTOR ALLEGES SUTURE NEEDLE APPARTENTLY DETACHED FROM SUTURE DURING SURGERY AND WAS FOUND TO BE IN THE MID-DESCENDING THORACIC AORTA. TWO(2) SUBSEQUENT RADIOLOGICAL PROCEDURES WERE PERFORMED TO RETRIEVE THE NEEDLE. ONE ON 5/8/98 AND ONE ON 5/9/98. THE NEEDLE WAS RETRIEVED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant POLYDEK SUTURE (ALLEGED) GAL GENZYME SURGICAL PRODUCTS CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention