BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 3565416 · Received December 23, 2013

    Report

    Report Number
    9615742-2013-02501
    Event Type
    Injury
    Date Received
    December 23, 2013
    Date of Event
    June 8, 2006
    Report Date
    December 19, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Description of Event or Problem · 1

    (INTERIM MEDICAL RECORDS DURING 06/08/2006-02/25/2009 ARE NOT AVAILABLE FOR REVIEW). ON (B)(6) 2009 - COMPLAINS OF VAGINAL SPOTTING THAT HAS BEEN OCCURRING FOR THE LAST 2 YEARS. THE BLEEDING HAS BEEN ESSENTIALLY PAINLESS. SHE IS USING ESTROGEN REPLACEMENT IN THE FORM OF CLIMARA PATCHES. IT IS FELT THAT THE EXPOSURE OF THE MESH IS RESPONSIBLE FOR THE BLEEDING - NOTED AVULSION ON THE LEFT ANTERIOR VAGINAL WALL WITH EXPOSURE OF THE MESH - VAGINAL BLEEDING SECONDARY TO VAGINAL AVULSION BY MESH - TO REMOVE THE EXPOSED MESH AND REPAIR THE VAGINAL AVULSION MESH REVISION SURGERY: (B)(6) 2009 - UNDERWENT EXCISION OF THE EXPOSED MESH AND REPAIR OF THE CHRONIC ULCERATION IN THE VAGINA UNDER GENERAL ANESTHESIA. (FURTHER MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672857 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVAULTA POSTERIOR SYSTEM OTN SOFRADIM PRODUCTION ZGB00593

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| CONCOMITANT THERAPY:| CONCOMITANT THERAPY:| AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM