BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 4965982 · Received August 4, 2015

    Report

    Report Number
    1213643-2015-00275
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    March 19, 2015
    Report Date
    July 20, 2015
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: DUE TO A TECHNICAL ISSUE, THE DATA IN THE FOLLOWING FIELDS WERE NOT TRANSMITTED ELECTRONICALLY IN THE PREVIOUS SUBMISSION: (B)(4)

    Additional Manufacturer Narrative · 1

    THE PATIENT REPORTED THAT THE EXPLANTING SURGEON NOTED THAT WHEN THE MESH WAS INITIALLY PLACED IT APPEARED TO NOT HAVE BEEN FLAT AT THAT TIME AND THIS WAS CAUSING SEVERE ADHESIONS TO THE SMALL BOWEL AND LIVER. THE WARNING SECTION OF THE IFU STATES, "CAREFUL ATTENTION TO SUTURE/STAPLE PLACEMENT AND SPACING WILL HELP PREVENT EXCESSIVE TENSION OR GAP FORMATION BETWEEN THE PATCH AND FASCIAL TISSUE." ADHESIONS IS A KNOWN AND ADHERENT RISK TO THE PROCEDURE AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE IFU AS A POSSIBLE COMPLICATION. ADDITIONALLY, THE PATIENT REPORTED THAT THE MESH WAS FOUND TO BE "CURLED UP/FOLDED" AND "DID NOT LAY FLAT." THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE WE ARE UNABLE TO REVIEW THE SAMPLE TO VERIFY THIS CONDITION AND EVALUATE FOR ROOT CAUSE. BASED ON THE INFORMATION PROVIDED, AT THIS TIME NO DEFINITIVE CONCLUSION CAN BE MADE AS TO THE DEGREE TO WHICH THE MESH IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED PATIENT OUTCOME. A REVIEW OF THE MANUFACTURING RECORDS SHOWS THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW UP 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 TO DAVOL VIA MAUDE EVENT REPORT (MW 5043138): "HAD HERNIA REPAIR 2006 WITH BARD KUGEL 3"X 3" CIRCLE THAT DID NOT LAY DOWN AND CAUSED EXTENSIVE ADHESIONS. MESH WAS LIFTED ON THE EDGE, WHICH DID NOT LAY DOWN AS IT WAS SUPPOSED TO ACCORDING TO SURGEON. I WAS IN SEVERE PAIN FOR THE PAST 3 YEARS. I EXPERIENCED ACID AND BILE BACK UP WHICH CAUSED BARRETT'S ESOPHAGUS AND A SLIDING HIATAL HERNIA CAUSING EXTREME PAIN. I HAD SURGERY ON 2015 TO REMOVE ADHESIONS AND ABDOMINAL PAIN STOPPED AND FOUL TASTE IN MOUTH STOPPED IMMEDIATELY. I AM STILL SUFFERING FROM THE HIATAL HERNIA PAIN AND WILL HAVE SURGERY IN THE NEAR FUTURE. ALSO I HAVE BONE LOSS IN MY JAW FROM EXTENSIVE TOXINS AND WILL BE HAVING SURGERY AS SOON AS HERNIA SURGERY IS DONE." PER FOLLOW UP WITH PATIENT: ON (B)(6) 2006 - UMBILICAL HERNIA REPAIR WITH THE IMPLANT OF A BARD/DAVOL KUGEL HERNIA PATCH. FOLLOWING IMPLANT THE PATIENT STATES THAT SHE BEGAN TO FEEL DISCOMFORT WHICH GRADUALLY TURNED TO PAIN. THE PATIENT SHE WAS TREATED FOR ANXIETY AND GERD. THE MEDICATIONS USED TO TREAT THE ANXIETY AND GERD WERE NOT RESOLVING THE ISSUES AND IN 2012 THE PAIN WORSENED AND THE PATIENT BEGAN TO HAVE TREMORS IN HER JAW, A FOUL TASTE IN HER MOUTH AND SOME DIFFICULTY BREATHING. ON (B)(6) 2015 - PARTIAL EXPLANT OF THE KUGEL HERNIA PATCH, WHICH THE PATIENT NOTES AS BEING "TRIMMED." THE PATIENT REPORTS THE SURGEON TOLD HER THE MESH WAS "CURLED UP/FOLDED" AND "DID NOT LAY FLAT." THE PATIENT REPORTS THAT THE SURGEON ALSO TOLD HER WHEN THE MESH WAS INITIALLY PLACED IT APPEARED TO NOT HAVE BEEN FLAT AT THAT TIME AND THIS WAS CAUSING SEVERE ADHESIONS TO THE SMALL BOWEL AND LIVER. DUE TO THE ADHESIONS, THE PATIENT WAS REPORTEDLY EXPERIENCING BILE BACK UP INTO THE ESOPHAGUS WHICH LED TO THE FOUL TASTE, DETERIORATION OF THE JAW BONE, THE INABILITY TO ABSORB ANY OF THE MEDICATION SHE WAS BEING TREATED WITH ORALLY AND EVENTUALLY SHE DEVELOPED A HIATAL HERNIA. THE PATIENT REPORTS SHE WILL UNDERGO FURTHER SURGERY TO "FIX HER ESOPHAGUS" AND ALSO TO CORRECT THE JAW BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506764 KUGEL PATCH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. 43CPD297

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention