BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 7396688 · Received April 4, 2018

    Report

    Report Number
    2210968-2018-71882
    Event Type
    Injury
    Date Received
    April 4, 2018
    Report Date
    March 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? IF YES, PROVIDE DETAILS OF EVENT AND SPECIFIC PRODUCT CODE. CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR EACH OF THE SUBJECTS OF THIS ARTICLE? IF YES, PLEASE INCLUDE: DATE AND TYPE OF PROCEDURE, WHERE PROCEDURE WAS PERFORMED, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT, PRODUCT INVOLVED, PRE-EXISTING CONDITIONS. ARE THE PRODUCT CODE AND LOT NUMBERS AVAILABLE FOR ETHICON DEVICES USED? CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY 182 (2014) 76¿8080; HTTP://DX.DOI.ORG/10.1016/J.EJOGRB.2014.08.030 - [(B)(4) - IGNJATOVIC 2014.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: SELF-CREATED TRANSOBTURATOR TAPE TREATMENT OF STRESS URINARY INCONTINENCE WITHOUT PRIOR URODYNAMIC INVESTIGATION¿. AUTHORS: IVAN IGNJATOVIC, MILAN POTIC, DRAGOSLAV BASIC, LJUBOMIR DINIC, NINA MEDOJEVIC, DARKO LAKETIC, ALEKSANDAR SKAKIC, AND MARIJA MIHAJLOVIC CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY 182 (2014) 76¿8080; HTTP://DX.DOI.ORG/10.1016/J.EJOGRB.2014.08.030 . THE AIM OF THIS STUDY WAS TO EVALUATE THE RESULTS OF THE TREATMENT OF STRESS URINARY INCONTINENCE (SUI), DIAGNOSED BASED ON PURE CLINICAL CRITERIA, WITH SELF-CREATED TRANSOBTURATOR TAPES (SCTOT) AND COMPARE THE RESULTS TO TREATMENT WITH INDUSTRIALLY CREATED TENSION FREE TAPE (ICTOT). THE STUDY INCLUDED 67 PATIENTS AGED 38 TO 79 WHO WERE TREATED WITH SCTOT AND COMPARED TO THE RESULTS OF THE SURGERY PERFORMED IN 47 PATIENTS AGED 41 TO 82 WHO WERE TREATED WITH ICTOT AFTER COMPLETE FOLLOW-UP. MONOFILAMENT SUTURES (PDS 2-0) WERE PASSED THROUGH BOTH ENDS OF THE POLYPROPYLENE MESH STRIPE TO MAKE A ¿¿COMPOSITE¿¿ SLING. BOTH ENDS OF THE MONOFILAMENT SUTURES WERE PASSED THROUGH HOLES AT THE END OF THE NEEDLE IN THE VAGINA. SUTURES WERE PULLED OUTSIDE AND THE MIDDLE OF THE SLING WAS TENSION-FREE AND PLACED BELOW THE URETHRA. THE VAGINA WAS SUTURED, AND THE VAGINAL PACK WAS LEFT IN SITU FOR 24 HOURS. POST-OPERATIVE COMPLICATIONS INCLUDED INFECTION (SCTOT N=5; ICTOT N=5), DE NOVO URGENCY (SCTOT N=4; ICTOT N=3), EXTERIORATION OF THE SLING (SCTOT N=1; ICTOT N=2) AND DYSPAREUNIA (SCTOT N=3; ICTOT N=2). ONE PATIENT FROM BOTH GROUPS WAS READMITTED TO THE HOSPITAL DURING THE FOLLOW UP FOR REOPERATION. IN CONCLUSION, SCTOT AFTER CLINICAL DIAGNOSIS OF SUI WAS MORE AFFORDABLE AND DOES NOT PRODUCE INFERIOR RESULTS COMPARED TO THE RESULTS REPORTED FOR INDUSTRIALLY CREATED SLINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238311 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention