BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 8928606 · Received August 23, 2019

    Report

    Report Number
    2210968-2019-86084
    Event Type
    Injury
    Date Received
    August 23, 2019
    Report Date
    July 31, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HERNIA (2006) 10: 380¿384 / DOI 10.1007/S10029-006-0107-1. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: INCISIONAL HERNIA TREATMENT WITH POLYPROPYLENE GRAFT: RESULTS OF 10 YEARS. THE PURPOSE OF THIS STUDY WAS TO REPORT THE RESULT OF TENSION-FREE REPAIR OF LARGE INCISIONAL HERNIA WITH POLYPROPYLENE MESH USING MODIFIED USHER TECHNIQUE. BETWEEN JAN 1994 AND DEC 2004, A TOTAL OF 291 PATIENTS [N=232 FEMALE, N=59 MALE, AVERAGE AGE 59 ± 12.6 YEARS (RANGE 20 TO 87 YEARS)] WITH AN INCISIONAL HERNIA OF MORE THAN 5 CM IN LENGTH WERE INCLUDED IN THE STUDY. THE FASCIA WAS EVALUATED FOR THE PRESENCE OF TENSION. WHEN NO TENSION WAS OBSERVED, PROLENE MESH (ETHICON) WAS PLACED ON THE FASCIA LEAVING A MARGIN OF 5 CM FROM THE SUTURE LINE ON EACH SIDE. THEN THE MESH WAS FIXED TO THE FASCIA BY INTERRUPTED 2/0 POLYPROPYLENE SUTURES PLACED 1 CM FROM THE SUTURE LINE ON EACH SIDE AND 2 CM DISTANT FROM EACH OTHER VERTICALLY ALONG THE GRAFT LENGTH. IN CASES OF VERY LARGE HERNIAS, THE HERNIA SAC WAS DISSECTED AND INCISED AT THE APPROPRIATE SITE DIVIDING THE SAC INTO TWO LEAVES. ONE LEAF WAS FIXED TO THE OPPOSITE FASCIA MARGIN JUST BENEATH THE OTHER LEAF. THE OTHER LEAF WAS FIXED TO THE OPPOSITE FASCIA MARGIN ON TOP OF THE FIRST LEAF WITH 2/0 VICRYL SUTURE (ETHICON) IN A CONTINUOUS PATTERN. POSTOPERATIVE COMPLICATIONS INCLUDED RECURRENCE (N=6); HEMATOMA FORMATION (N=2) WHICH SHOWED REGRESSION; SEROMA (N=4) WHICH NEEDED INTERMITTENT REPEATED ASPIRATIONS; INFECTION (N=8) WHEREIN SIX OF WHOM WERE TREATED WITH ANTIBIOTICS WITHOUT THE NEED FOR GRAFT EXCISION AND THE OTHER TWO HAD SERIOUS INFECTION NECESSITATING GRAFT REMOVAL WITH OPEN WOUND TREATMENT IN ADDITION TO ANTIBIOTIC ADMINISTRATION; AND SINUS FORMATION (N=2) WHICH WERE TREATED WITH CURETTAGE. BY USING THE MODIFIED TECHNIQUE WE CAN DECREASE THE EXPECTED COMPLICATIONS AFTER TENSION-FREE REPAIR OF LARGE INCISIONAL HERNIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718005 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention