BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 2082290 · Received May 9, 2011

    Report

    Report Number
    2210968-2011-00600
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAO
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT SURGICAL PROCEDURE ON (B)(6) 2011. THE SURGEON PERFORMED THE PROCEDURE ON THE LEFT CALF AND SUTURE WAS USED TO TEMPORARILY CLOSE AS A BRIDGE POST EXCISION WHILE WAITING FOR THE PATHOLOGY REPORT TO RETURN. THE PATIENT CAME BACK TO DOCTOR ON (B)(6) 2011 FOR FOLLOW UP AND WHEN THE DRESSING WAS REMOVED, IT WAS DISCOVERED THAT THE SUTURES HAD BROKEN. NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHILON NYLON SUTURE SUTURE, NON-ABSORBABLE GAO ETHICON, INC. NA CPE335

    Patients

    Seq Age Sex Outcome Treatment
    1