BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7931784 · Received October 3, 2018

    Report

    Report Number
    2210968-2018-76296
    Event Type
    Injury
    Date Received
    October 3, 2018
    Report Date
    September 10, 2018
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (INCISIONAL HERNIA AT SITE OF TROCAR ENTRY) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: HERNIA (2015) 19:879¿885, DOI 10.1007/S10029-015-1431-0, PUBLISHED ONLINE: 20 OCTOBER 2015 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: COMPARISON OF PERITONEAL CLOSURE TECHNIQUES IN LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL INGUINAL HERNIA REPAIR: A PROSPECTIVE RANDOMIZED STUDY" AUTHORS: H. OGUZ, E. KARAGULLE, E. TURK, G. MORAY. CITATION: HERNIA (2015) 19:879¿885, DOI 10.1007/S10029-015-1431-0, PUBLISHED ONLINE: 20 OCTOBER 2015 THE CURRENT STUDY AIMED TO COMPARE TACKER AND SUTURE TECHNIQUES FOR PERITONEAL CLOSURE WITH RESPECT TO PATIENT OUTCOMES. BETWEEN SEPTEMBER 2012 AND SEPTEMBER 2013, A TOTAL OF 64 PATIENTS WERE INCLUDED IN THE STUDY, 32 BEING IN THE TACKER GROUP (28 MALES, 4 FEMALES; AGE: 54.1 ± 16.3) AND 32 IN THE SUTURE GROUP (28 MALES, 4 FEMALES; AGE: 52.4 ± 16.4). ALL PATIENTS UNDERWENT LAPAROSCOPIC TAPP INGUINAL HERNIA REPAIR. IN ALL PATIENTS, AFTER THE REDUCTION OF THE HERNIAL SAC, AND IDENTIFICATION AND SATISFACTORY ANATOMICAL DELINEATION OF VAS DEFERENS AND THE OTHER CORD STRUCTURES AND CONTROLLING THE POSSIBLE HERNIA REGIONS, A PREPARED AND ROLLED 15 X 15 CM POLYPROPYLENE MESH (PROLENE; ETHICON (B)(4)) WAS INTRODUCED VIA THE UMBILICAL PORT INTO THE ABDOMEN. IN THE SUTURE GROUP THE PERITONEAL OPENING WAS CLOSED USING 2-0 POLYPROPYLENE SUTURE PUT CONTINUOUSLY (PROLENE; ETHICON (B)(4)). WHEN THE INTRAABDOMINAL CO2 WAS DESUFFLATED AND ALL TROCARS WERE REMOVED, 10 MM TROCAR SITE WAS CLOSED WITH 1-0 POLYGLACTIN 910 SUTURES (VICRYL; ETHICON (B)(4)). A TOTAL OF EIGHT PATIENTS EXPERIENCED A COMPLICATION IN THE TACKER GROUP. THESE COMPLICATIONS WERE POSTOPERATIVE URINARY RETENTION IN TWO PATIENTS AND SEROMA DIAGNOSED WITH PHYSICAL EXAMINATION THAT RECOVERED SPONTANEOUSLY WITHOUT ANY INTERVENTION IN THREE PATIENTS. ONE PATIENT DEVELOPED SCROTAL HEMATOMA THAT RECOVERED SPONTANEOUSLY WITHOUT OPERATION, ONE HAD CHRONIC GROIN PAIN, AND ONE HAD INCISIONAL HERNIA OF 10 MM SIZE AT THE SITE OF TROCAR ENTRY BELOW THE UMBILICUS. A TOTAL OF FIVE PATIENTS DEVELOPED COMPLICATIONS IN THE SUTURE GROUP. THESE INCLUDED POSTOPERATIVE URINARY RETENTION IN ONE PATIENT, AND SEROMA DIAGNOSED WITH PHYSICAL EXAMINATION THAT RECOVERED SPONTANEOUSLY WITHOUT ANY INTERVENTION IN FOUR PATIENTS. NO POSTOPERATIVE PORT-SITE INFECTION AND MESH INFECTION WERE OBSERVED. NONE OF THE PATIENTS SUFFERED INGUINAL HERNIA RECURRENCE. IN CONCLUSION, TACKER AND SUTURE APPEARED TO HAVE A COMPARABLE SAFETY FOR PERITONEAL CLOSURE IN LAPAROSCOPIC TAPP INGUINAL HERNIA OPERATION. IT CAN BE SUGGESTED THAT PERITONEAL CLOSURE WITH TACKER INCREASED SHORT-TERM PAIN, INDEPENDENT OF THE NUMBER OF TACKERS USED FOR MESH FIXATION. LONG-TERM PAIN WAS SIMILAR IN BOTH GROUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772802 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention