BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLITE

    MDR report key: 3082296 · Received April 23, 2013

    Report

    Report Number
    1219977-2013-00046
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 10, 2012
    Report Date
    March 25, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K930669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS AN INGUINAL HERNIA REPAIR. THERE WERE MULTIPLE OPERATIONS FOR HERNIA REPAIR PRIOR TO THE MESH IMPLANTATION, WHICH COULD HAVE LED TO SCARING. THE LAST HERNIA REPAIR WAS DONE USING THE ATRIUM MEDICAL MESH. THE PT CAME TO CJW MEDICAL DUE TO PAIN AND BLOOD IN THE URINE. THE UROLOGIST DIAGNOSED THE PROBLEM. THE PT HAD NO HISTORY OF BLADDER INFECTIONS AND THERE WAS NO RECORDS THAT THE PT HAD ANY ABDOMINAL SURGERY OR TRAUMA SINCE IMPLANTATION. THE FACILITY WAS CONTACTED THAT REMOVED THE PROLITE MESH IN ORDER TO OBTAIN ANY PRE-OPERATIVE, OPERATIVE (IMPLANTATION AND EXPLANTATION), AND FOLLOW-UP NOTES. THE RISK MANAGER STATED THAT THEY COULD NOT RELEASE THE NOTES. SHE STATED THE IMPLANTATION OCCURRED OVER 10 YEARS AGO SO ANY RECORDS FOR THE IMPLANTATION WOULD HAVE BEEN DESTROYED, PER VIRGINIA LAW. THE IMPLANTATION DID NOT OCCUR AT THE SAME FACILITY THAT REMOVED THE MESH, NOR WAS THE SAME SURGEON INVOLVED. A REVIEW OF THE INFO INVOLVED WITH THIS COMPLAINT WAS REVIEWED BY A 3RD PARTY CLINICIAN. BASED ON THE INFO PROVIDED IT IS OF THEIR CLINICAL OPINION THAT THE CLINICAL SCENARIO IS EROSION OF THE ATRIUM HERNIA MESH THAT HAD BEEN IMPLANTED IN THE INGUINAL AREA IN 2002 ONTO THE BLADDER BY OR BEFORE 10 YEARS LATER IN (B)(6) 2012. THERE IS NO EVIDENCE THAT INFECTION OF THE ATRIUM HERNIA MESH OCCURRED, AND THERE IS NO EVIDENCE THAT EROSION OF THE MESH CAUSED BLADDER INFECTION. INSTEAD, IT IS LIKELY THAT THE REPEATED SURGICAL PROCEDURES AND PREVIOUS IMPLANTATIONS OF HERNIA MESH WEAKENED THE ABDOMINAL AND PELVIC WALL ENOUGH TO ALLOW THE SUBSEQUENTLY IMPLANTED ATRIUM HERNIA MESH TO MOVE FROM THE INGUINAL AREA TO THE ADJACENT BLADDER ORGAN IN THE ABSENCE OF INFECTION.

    Description of Event or Problem · 1

    REFERENCE FDA MEDWATCH UF REPORT# (B)(4). PT WITH HISTORY OF HERNIA REPAIR WITH MESH IN 2002 PRESENTED TO THE UROLOGIST WITH GROSS PAINLESS HEMATURIA. CT SHOWED THICKENING OF THE RIGHT SIDE OF HIS BLADDER WALL ASSOCIATED WITH THIS MESH AND SOME CALCIFICATIONS. ALSO, NOTED WAS S SHRUNKEN LEFT KIDNEY AND A RIGHT RENAL CALCULUS. PLAN: CYSTOSCOPY WITH RETROGRADE; FOUND MESH THROUGH THE BLADDER MUCOSA EXPOSE TO URINE. SURGICAL INTERVENTION PLANNED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: (B)(6) 2002 - HERNIA REPAIR WITH MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174257 PROLITE FTL ATRIUM MEDICAL CORP. 1000606-00 22352822

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R