BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL (POLYGLACTIN 910) MESH

    MDR report key: 2032712 · Received March 17, 2011

    Report

    Report Number
    2210968-2011-00281
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    August 1, 2009
    Report Date
    February 14, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K810428
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - URINARY TRACT INFECTION. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A TOTAL PELVIC FLOOR REPAIR PROCEDURE ON (B)(6) 2009, AND MESH WAS USED. AN INDWELLING CATHETER WAS INSERTED FOR 2 WEEKS POST-OPERATIVELY. A BLADDER INFECTION OCCURRED ONE WEEK POST-OPERATIVELY AND IT RESOLVED WHEN THE PT WAS TREATED WITH LEVAQUIN. SINCE THE PROCEDURE, THE PT FEELS DISCOMFORT AND CAN OCCASIONALLY FEEL SOMETHING TOUCHING HER BLADDER AND/OR HER URETHRA. THE PT IS AWARE OF THESE SENSATIONS IN THE PELVIC FLOOR WHICH HAVE IMPROVED IN THE PAST YEAR. THE PT HAS HAD NUMEROUS DOCTOR VISITS TO THE SURGEON, GYNECOLOGIST AND UROLOGIST. TOPICAL ESTROGEN HELPS. THE PT ALSO SEES A PHYSICAL THERAPIST WHO PROVIDES AN INTERNAL MANUAL MASSAGE TO THE AREA WHICH ALSO HELPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICRYL (POLYGLACTIN 910) MESH MESH, SURGICAL, POLYMERIC GAM ETHICON, INC. NA BC2040

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention