BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2894142 · Received January 3, 2013

    Report

    Report Number
    2210968-2013-00072
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE PATIENT THAT HE HAD A CORONARY ARTERY GRAFT BYPASS SURGERY IN (B)(6) 2012 AND SUTURE WAS USED SUBCUTANEOUSLY. THE PATIENT HAS HAD PERSISTENT DRAINING SINUS TRACTS FROM THE STERNAL INCISION EIGHT MONTHS POST OPERATIVE. HE WAS TREATED WITH SEVERAL COURSES OF OUTPATIENT ANTIBIOTICS. THE PATIENT WAS EVALUATED BY AN INFECTIOUS DISEASE PHYSICIAN AND IV VANCOMYCIN THROUGH A PICC LINE WAS PRESCRIBED. HE WAS REOPERATED ON (B)(6) 2013 TO REMOVE ANY UNDERLYING FOREIGN BODIES WHICH COULD BE POTENTIALLY THE CAUSE OF THE AGGRAVATED INFECTION OR PERSISTENT DIFFICULTY WITH THE HEALING UNDER THE SINUS TRACTS. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-01394. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT HE HAD HEART BY PASS SURGERY IN (B)(6) 2012 AND SUTURE WAS USED. APPROXIMATELY 6 WEEKS POST OPERATIVE, HE BEGAN TO EXPERIENCE REDNESS AND PAIN AT THE INCISION SITE. APPROXIMATELY 2 MONTHS POST OPERATIVE, HE BEGAN TO DEVELOP BLISTERS AND OOZING AT THE SITE. THE PATIENT HAS BEEN PRESCRIBED ANTIBIOTICS AND REQUIRES AN ABSORBANT PAD TO ABSORB THE WOUND DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3675 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention