BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DMAX

    MDR report key: 8414026 · Received March 12, 2019

    Report

    Report Number
    1213643-2019-01630
    Event Type
    Injury
    Date Received
    March 12, 2019
    Report Date
    March 12, 2019
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741030734
    PMA / PMN Number
    K081010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED IS LIMITED TO THE JOURNAL ARTICLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING PRODUCT IDENTIFIERS. BASED ON THE INFORMATION PROVIDED IN THE ARTICLE THE CAUSE OF THE POSTOPERATIVE COMPLICATIONS CANNOT BE DETERMINED. PHOTOS WERE PROVIDED IN THE ARTICLE; HOWEVER, THE PHOTOS WERE OF POOR QUALITY AND DID NOT ASSIST IN DETERMINING THE REASON FOR THE PATIENT'S POSTOPERATIVE EXPERIENCE. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOT RETURNED.

    Description of Event or Problem · 1

    JOURNAL ARTICLE: TOTAL EXTRAPERITONEAL (TEP) MANAGEMENT OF MESH EROSION INTO BLADDER FOLLOWING TRANSABDOMINAL PREPERITONEAL INGUINAL HERNIA REPAIR (TAPP). HERNIA HTTPS://DOI.ORG/10.1007/S10029-018-1871-4. IN SUMMARY: A (B)(6) MALE CAME TO THE UROLOGY CLINIC AND PRESENTED WITH 1 WEEK HISTORY OF PAINLESS GROSS HEMATURIA, IT WAS NOT ASSOCIATED WITH THE FREQUENCY OF DYSURIA. HIS PAST MEDICAL HISTORY WAS QUITE NORMAL; OF NOTE, HE HAD UNDERGONE LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR (TAPP) 3 MONTHS AGO, AND A PREFORMED THREE DIMENSIONAL MESH (10.8 CM X 16 CM) WAS USED (DAVOL INC,USA). THE HERNIA REPAIR PROCEDURE WAS REPORTED UNCOMPLICATED. ON EXAMINATION, THERE WERE THREE HEALED SCARS ON THE ABDOMINAL WALL; THE REST OF THE ABDOMINAL EXAMINATION WAS UNREMARKABLE. ULTRASOUND SCAN IDENTIFIED AN IRREGULAR ABNORMAL ECHO INVOLVING THE LEFT ANTERIOR PORTION OF THE BLADDER. A CT SCAN CONFIRMED THE PRESENCE OF THICKENING CYST LIKE LESION OF THE LEFT ANTERIOR ASPECT OF THE BLADDER, PRESUMABLE WAS A TUMOR OR DIVERTICULUS. A CYSTOSCOPY WAS PERFORMED AND DEMONSTRATED A FOREIGN BODY OF NET STRUCTURE PROTRUDING INTO THE BLADDER LUMEN FROM THE LEFT ANTERIOR WALL OF THE BLADDER, AND IT WAS EVIDENT THAT THE FOREIGN BODY WAS FROM THE PREVIOUS HERNIA REPAIR WHICH WAS PERFORMED 3 MONTHS AGO. THE ELECTIVE LAPAROSCOPIC TOTAL EXTRAPERITONEAL APPROACH (TEP) WAS PERFORMED. THE DISSECTION IN THE PREPERITONEAL SPACE WAS MADE TOWARDS THE BLADDER AND THE PUBIC SYMPHYSIS; AS ANTICIPATED, THIS DISSECTION SHOWED EXTENSIVE SCARRING AND ADHESION FORMATION WITH DISRUPTION OF THE ANATOMIC LAYERS. AFTER CAREFUL DISSECTION, THE MESH WAS FOUND IN A FOLDING SHAPE, ADHERED TO THE BLADDER WALL, WITH A CORNER OF THE MESH INSIDE THE LEFT ANTERIOR OF THE URINARY BLADDER. THEN, THE MESH WAS DISSECTED OUT OF THE BLADDER AND WAS PARTIALLY EXCISED AROUND THE BLADDER DEFECT, LEAVING A DEFECT OF 2 CM X 2 CM ON THE LEFT ANTERIOR ASPECT OF THE BLADDER. THE BLADDER DEFECT WAS CLOSED IN TWO LAYERS WITH 2-0 BARBED SUTURE. HE WAS DISCHARGED FROM HOSPITAL DAYS AFTER THE URINARY CATHETER WAS REMOVED 3 WEEKS AFTER THE LAPAROSCOPIC PROCEDURE. NO SIGNS OF HERNIA RECURRENCE WERE OBSERVED DURING THE FOLLOW-UP PERIOD OF 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206495 3DMAX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI 00801741030734

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R