BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 3023462 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-02928
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAO
    PMA / PMN Number
    N85316
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCHES 2210968-2013-02926, 2210968-2013-02927, AND 2210968-2013-02929. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT ROTATOR CUFF SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT ALSO HAD A PIN IMPLANTED DURING THE SURGERY. APPROXIMATELY ONE WEEK POST OPERATIVE, THE PATIENT DEVELOPED REDNESS, SYSTEMIC WELTS, AND ANGIOEDEMA. OVER THE COURSE OF THE PAST YEAR THE SYMPTOMS HAVE RETURNED SPORADICALLY. THE SYSTEMIC SYMPTOMS HAVE SUBSIDED. THE INCISION HAS HEALED. HOWEVER, AT TIMES THE INCISION BECOMES RED AND SHE DEVELOPS WELTS. SHE HAS BEEN TREATED WITH ANTIHISTAMINES AND STEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126807 ETHILON NYLON SUTURE SUTURE, NON ABSORBABLE GAO ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PIN IMPLANT