BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 8894683 · Received August 14, 2019

    Report

    Report Number
    2210968-2019-85564
    Event Type
    Injury
    Date Received
    August 14, 2019
    Report Date
    July 16, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 (2009); 13:61¿66. DOI: 10.1007/S10029-008-0432-7. DOI: HTTP://DX.DOI.ORG/10.7602/JMIS.2014.17.2.30. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: COMPLEX INGUINAL HERNIA REPAIRS. THE PURPOSE OF THIS STUDY WAS TO REVIEW AN EXPERIENCE WITH THE OPEN PREPERITONEAL APPROACH USING MESHES FOR RECURRENT INGUINAL HERNIA (RIH) AND LARGE INGUINAL HERNIAS, AS WELL AS PROGRESSIVE PNEUMOPERITONEUM PREOPERATIVELY (PPP) IN VERY LARGE HERNIAS, TO DETERMINE THE APPLICABILITY, SAFETY, AND EFFICACY OF THE PROCEDURE. FROM JANUARY 1993 THROUGH DECEMBER 2007, 188 PATIENTS WITH UNILATERAL OR BILATERAL AVERAGE SIZE RIH, LARGE FIRST-TIME INGUINAL HERNIA (FTIH), OR LARGE RIH WERE SUBMITTED TO SURGICAL REPAIR. ONE HUNDRED AND TWENTY-ONE PATIENTS (110 MALE AND 11 FEMALE, AGE RANGE: 30-86 YEARS OLD) UNDERWENT NYHUS TECHNIQUE FOR UNILATERAL HERNIAS AND 67 MALE PATIENTS (AGE RANGE: 31 TO 85 YEARS OLD) UNDERWENT STOPPA REPAIR FOR BILATERAL HERNIAS, TOTALING 255 INGUINAL HERNIAS TREATED. IN NYHUS PROCEDURE, A TRANSVERSE INCISION WAS PERFORMED 2 CM ABOVE THE INTERNAL INGUINAL RING WITH A 7¿10-CM LONG INCISION. A LARGE PROLENE MESH (ETHICON) MEASURING 10 X 15 CM WAS USED. NUMBER 0 SUTURE POLYPROPYLENE (PROLENE, ETHICON) THREAD WAS USED TO FIX THE PROSTHESIS. IN STOPPA PROCEDURE, A MIDLINE LONGITUDINAL INCISION WAS PERFORMED, FROM THE UMBILICUS TO THE PUBIS. THE SAME POLYPROPYLENE PROLENE MESH (ETHICON) AND PROLENE THREADS (ETHICON) WERE USED. THE BOWEL WAS PUT BACK INTO THE PERITONEAL CAVITY, AND THE PERITONEUM WAS DIVIDED INTO TWO SEGMENTS, PROXIMAL AND DISTAL. THE PROXIMAL PART WAS CLOSED WITH VICRYL 3-0 (ETHICON). REPORTED COMPLICATIONS INCLUDED SMALL RECURRENT HERNIAS (N-2), SUPERFICIAL WOUNDS (N-2) WHICH HEALED IN 12 AND 15 DAYS AFTER DRAINAGE, LARGE HEMATOMA (N-6) AND SEROMA (N-26) WHICH WERE TREATED CONSERVATIVELY, HYDROCELE (N-15), AND SIGNIFICANT PAIN (N-27). IN CONCLUSION, AN ACCURATE OPEN PREPERITONEAL APPROACH USING MESH PROSTHESIS FOR COMPLEX INGUINAL HERNIAS IS SAFE, WITH VERY LOW RECURRENT RATES AND LOW MORBIDITY. PROGRESSIVE PREOPERATIVE PNEUMOPERITONEUM FOR GIANT HERNIAS WAS SHOWN TO BE AN IMPORTANT FACTOR IN ACCOMPLISHING GOOD INTRAOPERATIVE AND IMMEDIATE POSTOPERATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689058 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention