BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S/STEELMONO6DT202X18 X12

    MDR report key: 634686 · Received September 12, 2005

    Report

    Report Number
    9681850-2005-00021
    Event Type
    Injury
    Date Received
    September 12, 2005
    Date of Event
    August 1, 2005
    Report Date
    August 12, 2005
    Manufacturer
    GOSPORT - USS
    Product Code
    GAQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THE PATIENT EXPERIENCED A POST-OPERATIVE STERNAL DEHISCENCE. THE DOCTOR REPORTED THE CAUSE OF THE DEHISCENCE WAS THE STEEL SUTURE USED IN THE CASE SNAPPED AND FAILED. THE PATIENT WAS RESUTURED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S/STEELMONO6DT202X18 X12 STEEL SUTURE GAQ GOSPORT - USS * E4D0013C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other