BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX UGYTE PP 27X24CM X1

    MDR report key: 3796394 · Received January 16, 2014

    Report

    Report Number
    9615742-2014-00040
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Report Date
    October 1, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K033376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: PELVIC ORGAN PROLAPSE. A LITERATURE REVIEW TITLED COMPARISON BETWEEN TRANS-OBTURATOR TRANS-VAGINAL MESH AND TRADITIONAL ANTERIOR COLPORRHAPHY IN THE TREATMENT OF ANTERIOR VAGINAL WALL PROLAPSE: RESULTS OF A FRENCH RCT, IN THE JOURNAL OF INT UROGYNECOL J, DOI 10. 1007/S00192-13-2071-1, STATES A PROSPECTIVE STUDY WAS CONDUCTED BETWEEN APRIL 2005 AND DECEMBER 2009 IN 12 FRENCH HOSPITALS. ONE HUNDRED FORTY SEVEN PATIENTS WERE INCLUDED, 72 PATIENTS IN THE ANTERIOR COLPORRHAPHY GROUP USING 2/0 POLYGLACTIN SUTURE, AND 75 IN THE MESH GROUP, USING UGYTEX, WITH BOTH GROUPS PRESENTING WITH STAGE 2 OR MORE ANTERIOR VAGINAL WALL PROLAPSE. COMPLICATIONS IN THE MESH GROUP INCLUDED INTRA-OPERATIVE BLEEDING (1) , PARTIAL MESH SHRINKAGE (25, WITH 7 BEING PAINFUL), MESH EXPOSURE (7), AND RE-OPERATION (8). THIS FTR IS FOR THE PAIN EXPERIENCED WITH THE PARTIAL MESH SHRINKAGE. VAGINAL LENGTH DID NOT SHORTEN. SHRINKAGE WAS NOT SIGNIFICANTLY LINKED TO AGE, HYSTERECTOMY, PERVIOUS PROLAPSE SURGERY, HORMONE THERAPY OR CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42838 PARIETEX UGYTE PP 27X24CM X1 NONE FTL SOFRADIM PRODUCTION

    Patients

    Seq Age Sex Outcome Treatment
    1