BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9960711 · Received April 14, 2020

    Report

    Report Number
    2210968-2020-03052
    Event Type
    Injury
    Date Received
    April 14, 2020
    Report Date
    March 20, 2020
    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. ADDITIONAL INFORMATION REQUESTED AND FOLLOWING WAS OBTAINED: SURGICAL COMPLICATIONS IN THIS ARTICLE ARE NOT LACKING IN ETHICON PRODUCTS (VICRYL SUTURES). VICRYL SUTURE) HAS NO RELATION, EVEN WE ARE VERY SATISFIED. 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 (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED? CITATION: HTTPS://DOI.ORG/10.4174/ASTR.2019.97.5.261; [ANN SURG TREAT RES 2019;97(5):261-265]. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY JOURNAL ARTICLE WITH TITLE: INVERSE 'D' INCISION TECHNIQUE IN TREATMENT OF PILONIDAL SINUS DISEASE; EXCISION WITH MINIMAL TISSUE LOSS, CLOSURE WITHOUT TENSION AND LATERAL LOCATION OF THE SUTURE LINE. THE PRESENT PROSPECTIVE STUDY AIMED TO INVESTIGATE EARLY OUTCOMES OF SURGICAL EXCISION THROUGH THE INVERSE D INCISION BASED ON TISSUE LOSS, WOUND TENSION, AND SUTURE LINE LOCATION. BETWEEN JANUARY 2015 AND JUNE 2017, 80 ADULT PATIENTS WITH A MEAN AGE OF 27 YEARS, OF WHICH, 63 PATIENTS (78.8%) WERE MALE WITH CHRONIC SACROCOCCYGEAL PILONIDAL SINUS (PS) WHICH WAS SURGICALLY REMOVED BY SUBCUTANEOUS EXCISION WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, AFTER CAREFUL HEMOSTASIS, THE SUBCUTANEOUS TISSUE WAS APPROXIMATED USING 3-0 VICRYL SUTURES (JOHNSON & JOHNSON, NEW BRUNSWICK, NJ, USA). A NEGATIVE PRESSURE DRAIN WAS PLACED IN THE SUBCUTANEOUS SPACE. THE SKIN AT THE SINUS EXCISION SITE WAS CLOSED USING MATTRESS SUTURES. FIVE PATIENTS (6.3%) HAD EARLY POSTOPERATIVE SURGICAL SITE COMPLICATIONS (3 WOUND INFECTIONS AND 2 HEMATOMA). ONLY 2 PATIENTS REQUIRED POSTOPERATIVE ANALGESIA. NO GENERAL COMPLICATIONS WERE REPORTED. IN CONCLUSION, OUR PRESENT TECHNIQUE AIMS TO EXCISE THE SACROCOCCYGEAL PS SUBCUTANEOUSLY WITH MINIMAL TISSUE LOSS THROUGH A INCISION THAT FACILITATES SMOOTH APPROXIMATION OF WOUND EDGES AFTER PRIMARY CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420325 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1