BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7480944 · Received May 2, 2018

    Report

    Report Number
    2210968-2018-72545
    Event Type
    Injury
    Date Received
    May 2, 2018
    Report Date
    April 3, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    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. 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. 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 USED IN THIS PROCEDURE? CITATION: THE JOURNAL OF OBSTETRICS AND GYNECOLOGY OF INDIA. 2013; 63(5): 328 331. DOI: 10.1007/S13224-013-0396-0. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: PERIOPERATIVE COMPLICATIONS IN VAGINAL MESH PROCEDURES USING TROCAR IN PELVIC ORGAN PROLAPSE REPAIR¿ AUTHOR : DEMIRCI FUAT , BIRGUL KARAKOC , DEMIRCI OYA , DEMIRCI ELIF, AKMAN YAVUZ, KARAALP ERHAN, DOLGUN NIHAL CITATION: THE JOURNAL OF OBSTETRICS AND GYNECOLOGY OF INDIA. 2013; 63(5): 328 331. DOI: 10.1007/S13224-013-0396-0. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO DOCUMENT INTRAOPERATIVE AND EARLY POST-OPERATIVE COMPLICATIONS ASSOCIATED WITH THE USE OF VAGINAL MESH WITH TROCAR IN PELVIC ORGAN PROLAPSE (POP) REPAIR. A TOTAL OF 120 PATIENTS UNDERWENT VAGINAL REPAIR OF POP USING VAGINAL MESH WITH TROCARS AND WERE INCLUDED IN THE STUDY. OF WHICH, 31 PATIENTS UNDERWENT ANTERIOR MESH REPAIR (LIGHT MESH 10, AVAULTA 1, PERIGEE 1, AND PROLIFT 19); 35 PATIENTS UNDERWENT POSTERIOR MESH REPAIR (LIGHT MESH 2, POSTERIOR IVS 17, AND PROLIFT 16); AND 54 PATIENTS UNDERWENT ANTERIOR AND POSTERIOR MESH REPAIR (LIGHT MESH 8, PROLIFT 32, AND PROLIFT M 14). DURING THE SURGICAL PROCEDURE, A MIDLINE INCISION WAS MADE, WHICH INCLUDED FULL THICKNESS OF THE FIBROMUSCULAR WALL OF THE VAGINA. THE VAGINA WAS CLOSED WITHOUT ANY RESECTION OF VAGINAL TISSUE. NO ¿T INCISIONS¿ WERE ALLOWED TO REDUCE THE CHANCE OF MESH EXPOSURE IN THE PATIENTS WITH CUFF PROLAPSE. IN ALL OF THE SURGICAL GROUPS, REPORTED COMPLICATIONS INCLUDED URINARY INFECTION (N-5), FEBRILE MORBIDITY (N-5), PERINEAL ECCHYMOSIS (N-5), AND EARLY MESH EXPOSURE (N-1). IT WAS CONCLUDED THAT VAGINAL MESH PROCEDURES MAY BE DONE WITH RELATIVELY FEWER PERIOPERATIVE COMPLICATIONS. HOWEVER, THERE IS A NEED FOR MORE RANDOMIZED CONTROLLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321803 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention