BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S / STMONO5DT204X18 X12ROTO

    MDR report key: 1747966 · Received June 30, 2010

    Report

    Report Number
    9612501-2010-00033
    Event Type
    Injury
    Date Received
    June 30, 2010
    Date of Event
    May 18, 2010
    Report Date
    June 18, 2010
    Manufacturer
    DAVIS AND GECK CARIBE, LTD
    Product Code
    GAQ
    PMA / PMN Number
    K955723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: CARDIAC SURGERY. ACCORDING TO THE REPORTER: THE SUTURE BROKE TWO-WEEKS POST-OPERATIVELY AND THE PT EXPERIENCED SUTURE LINE OUTAGES. THERE WAS RE-OPERATION WHICH WAS COMPLETED UNDER GENERAL ANESTHESIA AND THE SURGEON USED ORIGINAL SUTURE TO REBIND. PT REMAINED IN HOSPITAL FOR FURTHER EVALUATION. CURRENT INFLAMMATION IS HIGH AND THERE WAS NO TISSUE DAMAGE OR ADDITIONAL BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S / STMONO5DT204X18 X12ROTO NON-ABSORBABLE SUTURE PRODUCT GAQ DAVIS AND GECK CARIBE, LTD D9M0243

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O