BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOFRADIM PRODUCT

    MDR report key: 3627821 · Received February 6, 2014

    Report

    Report Number
    9615742-2014-00087
    Event Type
    Injury
    Date Received
    February 6, 2014
    Report Date
    January 23, 2014
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: VAGINAL WALL REPAIR. ACCORDING TO THE REPORTER: AN ARTICLE TITLED BLADDER POLYPS FOLLOWING BARD AVAULTA ANTERIOR MESH VAGINAL WALL REPAIR IN THE JOURNAL OF INT UROGYNECOL J (2012) 23:1797-1799 STATES A RETROSPECTIVE REVIEW OF A POST MENOPAUSAL WOMAN WHO DEVELOPED BLADDER POLYPS FOLLOWING IMPLANTATION OF MESH. AT INSERTION OF A FOLEY CATHETER AFTER THE OPERATION, HEMATURIA WAS SEEN, WHICH SUBSEQUENTLY RESOLVED. UPON RECOVERY FROM ANESTHESIA, THE PT COMPLAINED OF NONSPECIFIC ABDOMINAL PAIN. FOUR DAYS LATER, SHE WAS DISCHARGED WITH THE ABDOMINAL PAIN PERSISTING. OTHER SYMPTOMS EMERGED LATER, INCLUDING VAGINAL DISCHARGE, PAINFUL VOIDING WITH MUCOUS AND BLOOD, AND URINARY INCONTINENCE. TREATMENT WITH ANTIBIOTICS HAD NO EFFECT. BECAUSE THE SYMPTOMS PERSISTED, THE PT UNDERWENT A COMBINED UROGYNECOLOGICAL EXAMINATION UNDER GENERAL ANESTHESIA, WHICH DEMONSTRATED NO EVIDENCE OF VAGINAL EROSION OR OTHER MESH RELATED PROBLEMS. CYSTOSCOPY REVEALED AN EXTREMELY ERYTHEMATOUS BLADDER WALL WITH A MASSIVE AMOUNT OF POLYPS ALONG THE ENTIRE WALL. MESH REMOVAL WAS PERFORMED. IMMEDIATELY AFTER SURGERY, THE ABDOMINAL PAIN AND VAGINAL DISCHARGE RESOLVED, AND THE PT COMPLETELY RECOVERED SIX WEEKS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76886 UNKNOWN SOFRADIM PRODUCT NONE FTL SOFRADIM PRODUCTION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other