BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE

    MDR report key: 3113512 · Received May 15, 2013

    Report

    Report Number
    2210968-2013-05572
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    K001625
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-05570 AND 2210968-2013-05571. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CABG PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. THE SUTURE DESWGAED EASILY DURING ROUTINE USE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214229 PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE SUTURE, NON ABSORBABLE GAW ETHICON, INC. NA GAB635

    Patients

    Seq Age Sex Outcome Treatment
    1