BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12602351 · Received October 9, 2021

    Report

    Report Number
    2210968-2021-09439
    Event Type
    Injury
    Date Received
    October 9, 2021
    Date of Event
    February 25, 2019
    Report Date
    October 8, 2021
    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 · 0

    (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, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS (ILEUS, TROCAR SITE INFECTION, INTRA-ABDOMINAL ABSCESS AND BLEEDING) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS STUDY? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (ILEUS, TROCAR SITE INFECTION, INTRA-ABDOMINAL ABSCESS AND BLEEDING)? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: OBESITY SURGERY (2019) 29:3500¿3507. HTTPS://DOI.ORG/10.1007/S11695-019-03971-9.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF LAPAROSCOPIC EMBEDDING TECHNIQUE AND OTHER TECHNIQUES FOR APPENDICEAL STUMP CLOSURE THIS STUDY AIMED TO INVESTIGATE THE EFFICACY AND SAFETY OF LAPAROSCOPIC EMBEDDING TECHNIQUE. PATIENTS (N=71) WHO UNDERWENT LAPAROSCOPIC EMBEDDING TECHNIQUE FOR APPENDICEAL STUMP BETWEEN JULY 2017 AND DECEMBER 2018 WERE INCLUDED IN THE STUDY. THE MEAN AGE WAS 34.81 + 1.88 YEARS AND THE MEAN BMI WAS 27.51 + 5.44 KG/M2. THE MEAN OPERATIVE TIME WAS 61.93 + 17.67 MINUTES. ALL PATIENTS WERE GIVEN GENERAL ANESTHESIA. AFTER GENERAL ANESTHESIA INDUCTION, A TEMPORARY FOLEY CATHETER AND AN OROGASTRIC TUBE WERE INSERTED TO PREVENT VISCERAL INJURY, AND THEY WERE REMOVED BEFORE THE PATIENT RECOVERED FROM ANESTHESIA. DISSECTION OF THE MESOAPPENDIX WAS PERFORMED WITH A 5 MM OR 10 MM BIPOLAR TISSUE SEALING SYSTEM (LIGASURE® VALLEYLAB, BOULDER, CO) AS CLOSE AS POSSIBLE TO MINIMIZE AT LEAST A PORTION OF THE DISSECTION. THE APPENDIX BASE IS EXPOSED TO THE APPENDIX BASE WITH 2/0 VICRYL AND IS SECURED BY ICK. AFTER THE CONTROL OF BLEEDING IN CASES OF NON-APPENDICITIS, THE OPERATION WAS STOPPED. THE FASCIA WAS CLOSED WITH 2/0 VICRYL AND THE SKIN WAS CLOSED WITH 4/0 INTRACUTANEOUS VICRYL SUTURE. ALL PATIENTS, EXCEPT THOSE WHO HAD NAUSEA OR VOMITING, BEGAN TO TAKE ORAL INTAKE AT THE 4TH HOUR POSTOPERATIVELY. DICLOFENAC SODIUM (75 MG TWICE DAILY, INTRAMUSCULAR) WAS ADMINISTERED FOR THE TREATMENT OF POSTOPERATIVE PAIN AND WAS REPLACED WITH NAPROXEN SODIUM (550 MG TWICE DAILY, PER ORAL) AFTER ORAL ADMINISTRATION. ALL FINDINGS OF THE APPLICATIONS FOR DRESSING CHANGES AND SUTURES AND POSTOPERATIVE COMPLICATIONS WERE RECORDED. IN PATIENTS WITH UNCOMPLICATED APPENDICITIS, FOUR PATIENTS DEVELOPED SURGICAL SITE INFECTION AND TWO PATIENTS HAD ILEUS; WHEREAS TWO PATIENTS DEVELOPED ILEUS AND THREE PATIENTS DEVELOPED SURGICAL SITE INFECTION IN COMPLICATED APPENDICITIS CASES. THE MEAN LENGTH OF HOSPITAL STAY WAS 38.92 + 25.90 HOURS. THE PATIENTS WERE FOLLOWED UP 30 DAYS AFTER THE OPERATION REPORTED POSTOP COMPLICATIONS INCLUDED N=4 ILEUS, N=5 TROCAR SITE INFECTION, N=1 INTRAABDOMINAL ABSCESS AND N=7 BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500157 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention