BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 11632143 · Received April 7, 2021

    Report

    Report Number
    2210968-2021-03128
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    June 18, 2020
    Report Date
    March 26, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE NOT RETURNED. 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 CLARIFY 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. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OPERATIVE COMPLICATIONS (SEROMA, DISCOMFORT ASSOCIATED WITH SEROMA, HEMATOMA, DEEP INFECTION ASSOCIATED WITH SEROMA AND PAIN ASSOCIATED WITH SEROMA) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (PROLENE SUTURE) USED IN THIS PROCEDURE? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (SEROMA, DISCOMFORT ASSOCIATED WITH SEROMA, HEMATOMA, DEEP INFECTION ASSOCIATED WITH SEROMA AND PAIN ASSOCIATED WITH SEROMA). WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. IF AVAILABLE, PLEASE PROVIDE PROLENE SUTURE PRODUCT CODES/LOT NUMBERS USED IN THESE CASES. CITATION: SPRINGER-VERLAG FRANCE SAS, PART OF SPRINGER NATURE 2020. HTTPS://DOI.ORG/10.1007/S10029-020-02251-1. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TITLE: USING LOCAL HEMOSTATIC TO PREVENT SEROMAS IN PATIENTS WITH LARGE INCISIONAL HERNIAS RANDOMIZED CONTROLLED TRIAL. THIS STUDY AIMED TO ANALYZE THE RESULTS OF A RANDOMIZED CONTROLLED TRIAL ON THE USE OF HAEMOBLOCK IN PATIENTS WITH LARGE INCISIONAL HERNIAS AND ULTRASOUND MONITORING OF THE POSTOPERATIVE WOUND. A TOTAL OF 66 PATIENTS WERE INCLUDED AND WERE RANDOMLY DIVIDED INTO TWO GROUPS: WITH USE OF HAEMOBLOCK (GROUP A, N = 33) AND WITHOUT THE USE OF HAEMOBLOCK (GROUP B, N = 33). SUBLAY RETROMUSCULAR REPAIR WITH MESH PROLENE IMPLANT (ESFIL STANDARD MESH PROLENE IMPLANT (LINTEX, RUSSIA) TO OVERLAP HERNIA DEFECT AND WAS FIXED USING EIGHT PROLENE TRANSAPONEUROTIC MONOFILAMENT LIGATURES PROLINE 3/0. HAEMOBLOCK 15 ML RETROMUSCULARLY AND 15 ML SUBCUTANEOUSLY WERE APPLIED IN GROUP A. ULTRASOUND MONITORING OF POSTOPERATIVE WOUNDS WAS DONE WHICH DETERMINES THE VOLUME OF FLUID COLLECTION IN THE WOUND. WOUNDS WERE DRAINED BY VACUUM SUCTION DRAINAGE. MEDIAN OF FOLLOW-UP WAS 33 DAYS. SIGNIFICANT DIFFERENCES WERE OBTAINED IN THE DURATION OF WOUND DRAINING, 2.6 ± 0.6 DAYS IN GROUP A VERSUS 4.1 ± 0.9 DAYS IN GROUP B (P = 0.002). IN GROUP A, THE LEVELS OF C-REACTIVE PROTEIN AND ALBUMIN WERE LESS IN THE SEPARATED DISCHARGE, AS WELL AS ITS TOTAL AMOUNT. DURING THE FIRST 12 DAYS, A SIGNIFICANTLY LOWER VOLUME OF FLUID COLLECTIONS WAS DETECTED IN PATIENTS OF GROUP A THAN IN PATIENTS OF GROUP B. WE NOTED A MORE RAPID SUBSIDENCE OF EXUDATIVE PROCESSES IN POSTOPERATIVE WOUNDS IN PATIENTS FROM GROUP A. THE NUMBER OF PUNCTURES WAS SIGNIFICANTLY HIGHER IN GROUP B (0.8 ± 1.0 VS. 0.2 ± 0.4, RESPECTIVELY, P = 0.003). THE TOTAL NUMBER OF PUNCTURE INTERVENTIONS IN GROUP A WAS SIX IN SIX PATIENTS, VERSUS 27 IN 14 PATIENTS IN GROUP B (P = 0.000). REPORTED COMPLICATIONS INCLUDED SEROMA (N=28), DISCOMFORT ASSOCIATED WITH SEROMA (N=3), HEMATOMA (1), DEEP INFECTION ASSOCIATED WITH SEROMA (N=1) AND PAIN ASSOCIATED WITH SEROMA (3). TYPE 0B SEROMA, WHICH AS TYPE I AND TYPE II IS NOT A COMPLICATION, WAS SIGNIFICANTLY MORE LIKELY TO OCCUR IN GROUP A AND REQUIRES NO TREATMENT IN BOTH GROUPS. DISCOMFORT AND PAIN ASSOCIATED WITH SEROMA WERE BOTH TREATED WITH NSAID FOR 1 DAY, SEROMA TYPE IVA WAS PUNCTURED, SEROMA TYPE IVB, DEEP INFECTION ASSOCIATED WAS TREATED WOUND REVISION AND DRAINAGE AND HEMATOMA WAS TREATED THROUGH WOUND REVISION AND DRAINAGE UNDER THE GENERAL ANESTHESIA. IN CONCLUSION, THE USE OF THE LOCAL HEMOSTATIC AGENT HAEMOBLOCK CAN REDUCE THE DURATION OF THE POSTOPERATIVE WOUND DRAINAGE, SHORTEN THE PERIOD OF INFLAMMATORY EXUDATIVE PROCESSES IN THE POSTOPERATIVE WOUND, SIGNIFICANTLY REDUCING THE NUMBER OF PUNCTURE INTERVENTIONS TO EVACUATE FLUID COLLECTIONS. IT ALSO REDUCES THE RISK OF COMPLICATIONS, SUCH AS SPONTANEOUS DRAINAGE OF SEROMA THROUGH A POSTOPERATIVE WOUND, SURGICAL SITE INFECTIONS ASSOCIATED WITH SEROMA. IT DECREASES THE DURATION OF DRAINAGE AND THE NUMBER OF PUNCTURE INTERVENTIONS, REDUCING THE SEVERITY OF PAIN AND THE NEED FOR ANALGESICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529409 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ESFIL STANDARD MESH (LINTEX)RUSSIA