BEUDAMED
    FDA Adverse Event Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2141574 · Received June 17, 2011

    Report

    Report Number
    2210968-2011-00786
    Date Received
    June 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K946271
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A LINK TO AN INTERNET SUTURE SITE THAT A PT UNDERWENT A PARTIAL VULVECTOMY PROCEDURE IN 1997 AND SUTURE WAS USED. (B)(6) AFTER THE PROCEDURE, THE PT EXPERIENCED VULVA BURNING PAIN FOR MONTHS. A SECOND PHYSICIAN CAUTERIZED AREAS ALONG THE INCISION LINE. ON BOTH SIDES OF THE INCISION LINE THERE WERE LITTLE OPENINGS AND THE PHYSICIAN BELIEVED THE SUTURES LEFT IN, THERE WERE TRAPPED IN SCAR TISSUE AND WERE TRYING TO MAKE THEIR WAY OUT TO THE SURFACE. THE PT UNDERWENT BETWEEN 50-55 CAUTERIZATIONS. THE PT HAS HAD TO TAKE MEDICATION FOR PAIN AND DEPRESSION AND WAS SUICIDAL AT ONE POINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention