BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7848499 · Received September 5, 2018

    Report

    Report Number
    2210968-2018-75652
    Event Type
    Injury
    Date Received
    September 5, 2018
    Report Date
    August 20, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K063562
    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. CITATION: TAIWANESE JOURNAL OF OBSTETRICS AND GYNECOLOGY. 2012; 51: 656 659. DOI: HTTP://DX.DOI.ORG/10.1016/J.TJOG.2012.09.027. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: DIFFERENT MANAGEMENT STRATEGIES FOR POSTOPERATIVE HEMATOMA AFTER PELVIC ORGAN PROLAPSE SURGERY" AUTHORS: CHI-YUAN LIAO, DAH-CHING DING CITATION: TAIWANESE JOURNAL OF OBSTETRICS AND GYNECOLOGY. 2012; 51: 656 659. DOI: HTTP://DX.DOI.ORG/10.1016/J.TJOG.2012.09.027. THIS REPORT DESCRIBES A PATIENT WITH POP WHO UNDERWENT TWO DIFFERENT OPERATIONS AND DEVELOPED A HEMATOMA AFTER EACH OPERATION. A (B)(6) FEMALE, G2P2, HAD STAGE 2 POP. SHE UNDERWENT A PELVIC RECONSTRUCTION OPERATION WITH AN UNANCHORED PROSIMA MESH (ETHICON). SURGEONS PLACED GRAFTS ACCORDING TO THE MANUFACTURER¿S INSTRUCTIONS. THE PROCEDURES WERE SMOOTH DURING ANTERIOR PROSIMA PLACEMENT. ON DAY 2 POST-OPERATIVELY, THE PATIENT EXPERIENCED PRE-SACRAL HEMATOMA DUE TO BLEEDING FROM THE INTERNAL PUDENDAL ARTERY. A TRANS-ARTERIAL EMBOLIZATION AND CONSERVATIVE MANAGEMENT OF THE PELVIC HEMATOMA WERE PERFORMED. THE VAGINAL SUPPORT DEVICE AND POSTERIOR MESH WERE REMOVED DUE TO CONTINUOUS HEMORRHAGE ON POST-OPERATIVE DAY 15. ANTIBIOTICS WERE ALSO GIVEN FOR THE PREVENTION OF INFECTION. THE RESOLUTION OF THE PELVIC HEMATOMA TOOK 71 DAYS. IN THE LAST FEW YEARS, SEVERAL MESH AUGMENTATION SYSTEMS FOR PELVIC RECONSTRUCTION SURGERY, INCLUDING THE PROSIMA SYSTEM HAVE BEEN MARKETED. INITIAL REPORTS FROM THE MANUFACTURER HAVE IDENTIFIED A 2.5% RISK OF POSTOPERATIVE COMPLICATIONS, INCLUDING A 1.75% HEMATOMA RISK. ALL SURGEONS SHOULD BE AWARE OF THE POTENTIAL COMPLICATIONS ASSOCIATED WITH THESE NEW PELVIC RECONSTRUCTION TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690265 PROSIMA PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention