BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9503877 · Received December 20, 2019

    Report

    Report Number
    2210968-2019-91174
    Event Type
    Injury
    Date Received
    December 20, 2019
    Report Date
    December 5, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS INVOLVED? CITATION: GLAND SURG 2019;8(3):242-248; DOI: 10.21037/GS.2018.12.04. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE"TITLE: THE USE OF PLASMAKINETIC CAUTERY COMPARED TO CONVENTIONAL ELECTROCAUTERY FOR DISSECTION OF ABDOMINAL FREE FLAP FOR BREAST RECONSTRUCTION: SINGLE-CENTRE, RANDOMIZED CONTROLLED STUDY". AUTHOR : WHITNEY T. H. CHOW, GEORGETTE ONI, VENKAT V. RAMAKRISHNAN, MAT GRIFFITHS. CITATION: GLAND SURG 2019;8(3):242-248; DOI: 10.21037/GS.2018.12.04. THIS PROSPECTIVE RANDOMIZED BLINDED STUDY AIMED TO INVESTIGATE WHETHER THE USE OF THE PLASMAKINETIC CAUTERY CONFERS CLINICAL BENEFITS OVER CONVENTIONAL ELECTROCAUTERY DIATHERMY IN ABDOMINAL FLAP DISSECTION DURING BREAST RECONSTRUCTION. FROM JANUARY 2014 TO NOVEMBER 2014, A TOTAL OF 40 PATIENTS WERE BLINDLY RANDOMIZED TO EITHER ¿GROUP 1- CONVENTIONAL ELECTROCAUTERY¿ (N=20, MEAN AGE: 55 YEARS, MEAN BMI: 29 KG/M2) OR ¿GROUP 2-PLASMAKINETIC CAUTERY¿ (N=20, MEAN AGE: 54 YEARS, MEAN BMI 27.9 KG/M2) WITH THE RATIO OF 1:1, FOR THE DISSECTION OF THE ABDOMINAL FREE FLAP. DURING SURGERY, BLEEDING VESSELS WERE CAUTERIZED EXCEPT FOR LARGE PERFORATING BRANCHES, WHICH WERE CLIPPED WITH LIGACLIPS (ETHICON). VICRYL MESH (ETHICON) WAS ROUTINELY PLACED UNDER THE RECTUS SHEATH ON CLOSURE. THE CLOSURE OF THE ABDOMINAL WOUND IN LAYERS WITH 3/0 VIRCYL (ETHICON) TO THE FASCIA, STRATAFIX BARBED SUTURES (ETHICON) TO DERMIS AND DERMBOND TOPICAL SKIN ADHESIVE (ETHICON) FOR WOUND FINAL APPROXIMATION. COMPLAINTS INCLUDED SEROMA FORMATION (N=27) WHERE 4, 14 AND 9 SEROMAS WERE DETECTED AT DAYS 7, 14 AND 42 POST-OPERATION RESPECTIVELY AND ONLY ONE SEROMA REQUIRED DRAINAGE DURING THEIR OUTPATIENT VISIT AT 14 DAYS POST-OPERATION. OTHER COMPLAINTS ARE HEMATOMA (N=3) WHICH REQUIRED FURTHER SURGERY TO EVACUATE THE HEMATOMA, AND SUSPECTED WOUND INFECTION (N=1) WHO NEED ANTIBIOTICS POST-DISCHARGE. IN CONCLUSION, THIS STUDY DEMONSTRATES THAT THERE ARE NO SIGNIFICANT DIFFERENCES BETWEEN THE USE OF PLASMAKINETIC CAUTERY AND CONVENTIONAL ELECTROCAUTERY FOR ABDOMINAL FREE FLAP DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298017 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention