BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN HERNIA GRAFT

    MDR report key: 4092141 · Received August 21, 2014

    Report

    Report Number
    1835959-2014-00915
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    May 6, 2014
    Report Date
    August 19, 2014
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTL
    PMA / PMN Number
    K062697
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION INVESTIGATION INTO THIS FEEDBACK INCLUDED A REVIEW OF THE DETAILS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS, WHICH INDICATED THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS, AND A REVIEW OF THE IFU. SUMMARY OF INVESTIGATION FINDINGS THE ROOT CAUSE OF THE REPORTED SEROMA IS POTENTIALLY RELATED TO INADEQUATE DRAIN USAGE OR EARLY DRAIN REMOVAL. THE PATIENT REPORTEDLY EXPERIENCED EXCESSIVE DRAINAGE, HOWEVER, THE AMOUNT OF DRAINAGE THAT WAS STILL PRESENT AT THE TIME OF DRAIN REMOVAL WAS NOT PROVIDED. THE ROOT CAUSE OF THE DEHISCENCE OF AN OLD INCISION APPEARS TO BE SECONDARY TO THE "TIGHT BELLY" THE PATIENT EXPERIENCED. THE EXPULSION OF PORTIONS OF THE GRAFT AND THE GRAFT NOTED TO BE FLOATING IN THE FLUID IN THE EMPTY SPACE IS LIKELY RELATED TO THE FACT THAT THE GRAFT WAS NOT "IN MAXIMUM POSSIBLE CONTACT WITH HEALTHY, WELL-VASCULARIZED TISSUE" WHICH THE IFU NOTES AS THE IFU SUGGEST IN ORDER TO "ENCOURAGE CELL INGROWTH AND TISSUE REMODELING." ADDITIONALLY, THE PATIENT HAS A HISTORY OR DIABETES, WHICH CAN AFFECT THE PATIENT'S ABILITY TO HEAL. THE ROOT CAUSE OF THE PRURITIS THE PATIENT EXPERIENCED IS INCONCLUSIVE. THE PHYSICIAN INDICATED THIS COULD BE AN ALLERGIC REACTION TO THE GRAFT. OTHER POSSIBLE CAUSES OF THE PRURITIS COULD BE RELATED TO THE AMOUNT OF SWELLING THAT WAS PRESENT WITH THE "TIGHT BELLY", OTHER UNDERLYING HEALTH CONDITIONS, OR A REACTION TO MEDICATIONS.

    Description of Event or Problem · 1

    DR (B)(6) IMPLANTED A BIODESIGN HERNIA GRAFT INTO AN (B)(6) YEAR OLD MALE PT ON (B)(6) 2014. THE PT HAD A HISTORY OF AN GASTRECTOMY 2 YEARS PRIOR AND DIABETES CONTROLLED WITH MEDICATION. THE GRAFT WAS PLACED VIA LAPAROSCOPIC INTRAPERITONEAL ONLAY METHOD FOR REPAIR OF AN INCISIONAL HERNIA. A DRAIN WAS PLACED DURING THE INITIAL SURGERY AND REMOVED APPROXIMATELY ONE MONTH LATER. DURING THIS TIME, THERE WAS EXCESSIVE DRAINAGE FLUID. APPROXIMATELY TWO WEEKS POST DRAIN REMOVAL, THE PATIENT DEVELOPED, WHAT WAS DESCRIBED AS, TIGHT BELLY WHICH WAS SUSPICIOUS OF SEROMA FORMATION AND WAS ACCOMPANIED WITH PRURITIS. THE PATIENT DID NOT CONSULT WITH THE SURGEON UNTIL THE PRURITIS AND LIGHT BELLY BECAME MORE SERIOUS (TIME FRAME UNSPECIFIED, BUT APPEARS TO BE APPROXIMATELY 2 MONTHS POST-OP). AT THAT POINT, THE TIGHT BELLY LED TO DEHISCENCE OF AN OLD WOUND AND PORTIONS OF THE GRAFT WERE EXPELLED THROUGH THE DEHISCENCE. ORIGINAL INFORMATION REPORTED THE PATIENT ALSO EXPERIENCED FEVER DURING THIS TIME. HOWEVER, THE SURGEON INDICATED THERE WAS NO CONTINUOUS SLIGHT FEVER AFTER THE PATIENT WAS DISMISSED FROM THE HOSPITAL. PROFESSOR (B)(6) CONSULTED WITH DR. (B)(6) REGARDING THIS PATIENT AND THEN PERFORMED A WOUND DEBRIDEMENT AND FLUID DRAINAGE ON THE PATIENT. THE REOPERATION REVEALED AN EMPTY SPACE IN THE ABDOMINAL WALL WITH SOME PART OF THE IMPLANTED GRAFT FLOATING IN THE FLUID PRESENT IN THE SPACE. SOME OF THE GRAFT WAS DETACHED FROM THE EDGE OF THE SPACE AND SOME OF THE GRAFT HAD BEEN REMODELED INTO VASCULARIZED TISSUE. ONCE THE EMPTY SPACE WAS DRAINED, IT WAS FOUND TO LACK VASCULARIZATION AND WAS BLOODLESS. AFTER THIS SURGERY, THE PATIENT'S DISCOMFORT AND PRURITUS WAS RELIEVED AND THE PATIENT BEGAN TO RECOVER WELL. IN (B)(6), APPROXIMATELY 20 DAYS AFTER THE PREVIOUS OPERATION, PROFESSOR (B)(6) PERFORMED A WOUND DEBRIDEMENT AND WOUND CLOSURE ON THE PATIENT. THE PATIENT REPORTEDLY CONTINUED TO RECOVER WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504944 BIODESIGN HERNIA GRAFT COMPLEX HERNIA GRAFT EXL FTL COOK BIOTECH, INC. LB667412

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R