BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 2032035 · Received March 28, 2011

    Report

    Report Number
    2210968-2011-00354
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ETHICON, INC. SAN LORENZO
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/28/2011. (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT: REPRESENTATIVE SAMPLES OF THE PRODUCT WERE RETURNED FOR EVALUATION. THE SUTURE WERE INSPECTED AND TESTED FOR SUTURE TENSILE STRENGTH. THERE WERE NO SIGNS OF MANUFACTURING OR MATERIAL DEFECTS FOUND. CONCLUSION: NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPECIFICATION. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAPH PROCEDURE ON (B)(6) 2011. AFTER THE PROCEDURE WHEN THE PATIENT WAS IN THE CORONARY CARE UNIT, THE SUTURE BROKE WHEN THE PATIENT WAS COUGHING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL STAINLESS STEEL SUTURE SUTURE, NON-ABSORBABLE GAQ ETHICON, INC. SAN LORENZO NA BLR452

    Patients

    Seq Age Sex Outcome Treatment
    1