BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - DART

    MDR report key: 6653840 · Received June 20, 2017

    Report

    Report Number
    1213643-2017-00362
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    August 1, 2015
    Report Date
    June 20, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016578
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. IT IS STATED IN THE MAUDE EVENT REPORT THAT "THERE WAS A BACTERIAL TEST ALSO THAT CAME BACK POSITIVE." REGARDING INFECTION THE WARNING SECTION OF THE IFU STATS, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." DAVOL HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE PATIENT TO REQUEST ADDITIONAL INFORMATION. TO DATE NO ADDITIONAL DETAILS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED TO DATE, NO CONCLUSION CAN BE MADE. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW 5069673): " I HAD A SMALL UMBILICAL HERNIA THAT I NOTICED IN 2007. MY PRIMARY CARE SENT ME TO A SURGEON. ALTHOUGH VERY SMALL I WAS TOLD SURGERY WAS NEEDED. IT WAS SCHEDULED FOR EARLY 2008 AND PERFORMED ON (B)(6) 2008. ACCORDING TO THE SURGEON MY HERNIA WAS ACTUALLY LARGER THAN APPEARED AND STATED HE FOUND ANOTHER HERNIA WHILE REPAIRING THE SCHEDULED ONE. I DON'T RECALL ANY PAIN OR DISCOMFORT IN THE UPPER AREA WHERE THE SMALL EPIGASTRIC HERNIA WHICH CONTAINED A SMALL AMOUNT OF FAT WAS FOUND. I ONLY FIND ONE STICKER THAT SHOWS A DAVOL BARD MESH DART, SMALL MONOFILAMENT KNITTED POLYPROPYLENE, SIZE SMALL DART, REF 0112730 LOT 43AOD015, THAT WAS USED FOR THE REPAIR OR REPAIRS. I FIND NO SCARS OR REPAIR INDICATION ABOVE THE UMBILICAL REPAIR NO WHERE. NO DISCOMFORT AFTER SURGERY IN THE UPPER AREA AT ALL. EXTREME PAIN IN RECOVERY AROUND MY BELLY BUTTON AND INNER INTESTINAL AREA. I WAS LITERALLY SCREAMING IN PAIN. APPROXIMATELY 7 YEARS LATER I STARTED HAVING DISCOMFORT IN THE WHOLE INTESTINAL AREA AND MY PRIMARY CARE STARTED TESTING TO SEE WHAT COULD BE WRONG. WE DIDN'T SUSPECT ANOTHER HERNIA. MY DOCTOR THOUGHT MAYBE GALL STONES. AFTER MANY TESTS OVER APPROXIMATELY TWO YEARS, STILL NO ANSWERS BUT PAIN HAS INCREASED AND PRETTY MUCH BED RIDDEN FOR THE LAST 9-10 MONTHS. I HAVE HAD SCOPE THROUGH MY PENIS AT UROLOGIST DUE TO BLOOD IN MY URINE, CT SCAN FOR POSSIBLE PROSTATE ISSUES, PHYSICAL PROSTATE EXAM, CT SCAN WITH DYE, AND A DIAGNOSIS OF RAPID GASTRIC EMPTYING ALSO KNOWN AS DUMPING SYNDROME AND ANOTHER INTESTINAL ISSUE THAT CAUSES SOME FOOD OR LIQUID INTAKE TO REMAIN IN AN AREA OF INTESTINES INSTEAD OF GOING WITH THE REST. THERE WAS A BACTERIAL TEST ALSO THAT CAME BACK POSITIVE. I HAVE HAD BLOOD IN MY URINE FOR ALMOST TWO YEARS NOW, IT HURTS TO URINATE, SOMETIMES SEVERLY, AND BLOOD HAS SHOWN IN MY STOOLS ON OCCASIONS DURING THE LAST FEW YEARS. EVERYTHING POINTS TO COMPLICATIONS FROM THE HERNIA SURGERY WHICH I RECENTLY LEARNED ABOUT AND SEE THAT I HAVE ALMOST ALL OF THE SIDE EFFECTS INCLUDING NIGHTLY DRENCHING SWEATS. I BELIEVE I HAVE SOME TYPE OF MESH MIGRATION. NOTHING ELSE HAS PINPOINTED MY SYMPTOM OR COME CLOSE. I CAN'T DEAL WITH THE PAIN MUCH LONGER AND NEED A SURGEON WHO IS EXPERIENCED IN THIS AREA. SO I BELIEVE THE DAVOL BARD MESH IS THE ISSUE AND SHOULD BE RECALLED BEFORE ANYONE ELSE HAS TO ENDURE WHAT I'M GOING THROUGH. I NEED HELP BAD!"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433880 MESH - DART SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43AOD015 00801741016578

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S