BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 3935904 · Received June 26, 2014

    Report

    Report Number
    3004170064-2014-00147
    Event Type
    Other
    Date Received
    June 26, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 26, 2014
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    PMA / PMN Number
    060984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND EVERYTHING WAS IN ORDER.

    Description of Event or Problem · 1

    THIS IS BEING REPORTED AS AN ADVERSE EVENT THAT OCCURRED AS PART OF THE (B)(4) STUDY. THE PATIENT HAD SURGERY SCHEDULED TO UNDERGO PELVIC FLOOR REPAIR INCLUDING SACROSPINOUS LIGAMENT SUSPENSION, CYSTOCELE REPAIR, NATIVE TISSUE RECTOCELE REPAIR AND RETROPUBIC SLING. ONE DEVICE WAS IMPLANTED ON (B)(6) 2014 ALONG WITH A TRANSOBTURATOR SLING (NOT IDENTIFIED) WITHOUT COMPLICATIONS. ON (B)(6) 2014, THE PATIENT EXPERIENCED CONSTIPATION OF MODERATE SEVERITY CAUSING RECTAL AND ABDOMINAL PAIN RELATED TO MUSCLE SPASMS. THE EVENT WAS RESOLVING ON (B)(6) 2014. THE PHYSICIAN ASSESSED THE EVENT AS PELVIC FLOOR RELATED; DEFINITELY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE DEVICE. (THE DEVICE WAS NOT SPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374805 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. 830-247 1308016

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention