BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 3952404 · Received July 11, 2014

    Report

    Report Number
    3004170064-2014-00157
    Event Type
    Other
    Date Received
    July 11, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 11, 2014
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    PMA / PMN Number
    060984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS BEING REPORTED AS AN ADVERSE EVENT THAT OCCURRED AS PART OF THE FDA 522 ORDER POST-MARKET SURVEILLANCE STUDY. THE PT HAD SURGERY SCHEDULED TO UNDERGO APICAL SUSPENSION AND CYSTOCELE REPAIR. THE PT ALSO HAD CONCOMITANT ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY, NATIVE TISSUE ENTEROCELE AND RECTOCELE REPAIR AND TRANSOBTURATOR SLING PLACEMENT. ONE DEVICE WAS IMPLANTED ON (B)(6) 2014 ALONG WITH A TRANSOBTURATOR SLING (NOT IDENTIFIED) WITHOUT COMPLICATIONS. ON (B)(6) 2014, FOLLOWING CATHETER REMOVAL, THE PT WAS UNABLE TO VOID (ALSO ON (B)(6) 2014). THE PT WAS DISCHARGED WITH A FOLEY CATHETER. THE EVENT WAS REPORTED TO BE MODERATE IN SEVERITY BUT RESOLVED ON (B)(6) 2014. THE PHYSICIAN ASSESSED THE EVENT AS PELVIC FLOOR RELATED; PROBABLY RELATED TO THE PROCEDURE AND PROBABLY RELATED TO THE DEVICE (THE DEVICE WAS NOT SPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407050 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention