BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE

    MDR report key: 3030450 · Received April 2, 2013

    Report

    Report Number
    2210968-2013-03267
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    K001625
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR TENSILE STRENGTH AND THEY MET THE REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    (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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2210968-2013-03268. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133979 PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE SUTURE, NON ABSORBABLE GAW ETHICON, INC. NA EKR055

    Patients

    Seq Age Sex Outcome Treatment
    1