BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7902448 · Received September 24, 2018

    Report

    Report Number
    2210968-2018-75945
    Event Type
    Injury
    Date Received
    September 24, 2018
    Report Date
    August 29, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K063562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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: ABSTRACTS / JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. 2016; 23: S1¿S252. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: LAPAROSCOPIC EXCISION OF THE ¿¿WADDED¿¿ APICAL VAGINAL MESH" AUTHORS: ELKATTAH R, MOHLING S, FURR R. CITATION: ABSTRACTS / JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. 2016; 23: S1¿S252. THE PATIENT IS A (B)(6) CAUCASIAN WOMAN WHO UNDERWENT PLACEMENT OF A PROSIMA (ETHICON) ANTERIOR VAGINAL WALL KIT MESH FOR STAGE 2 ANTERIOR VAGINAL WALL PROLAPSE. REPORTED COMPLICATION INCLUDED RECURRENT STAGE 2 ANTERIOR VAGINAL WALL PROLAPSE, STAGE 2 APICAL UTEROVAGINAL PROLAPSE, AND DYSPAREUNIA. THIS WAS HIGHLY SUGGESTIVE OF MESH THAT HAD MIGRATED FROM ITS ORIGINAL PLANE AND ¿¿WADDED-UP¿¿ WITHIN THE APICAL VAGINAL AREA. THE PATIENT UNDERWENT A LAPAROSCOPIC APICAL VAGINAL MESH EXCISION, TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND OVARIAN PRESERVATION FOLLOWED BY A BILATERAL UTEROSACRAL LIGAMENT SUSPENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743670 PROSIMA PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention