BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN HERNIA GRAFT

    MDR report key: 15575967 · Received October 11, 2022

    Report

    Report Number
    1835959-2022-00007
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    August 7, 2012
    Report Date
    October 5, 2022
    Manufacturer
    COOK BIOTECH
    Product Code
    OXK
    UDI-DI
    10827002360324
    PMA / PMN Number
    K133306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION INVESTIGATION INTO THIS FEEDBACK INCLUDED 1) A REVIEW OF THE FEEDBACK DETAILS, 2) A REVIEW OF THE DEVICE LOT HISTORY RECORD, 3) A REVIEW OF THE CBI COMPLAINT DATABASE, AND 4) A REVIEW OF THE BIODESIGN SURGISIS 8-LAYER TISSUE GRAFT/SURGISIS HERNIA GRAFT IFU FP0036-2H. UPDATE: ADDITIONAL INVESTIGATION INTO THIS FEEDBACK INCLUDED A REVIEW OF MEDICAL RECORDS RECEIVED ON (B)(6) 2022. UPDATE: ADDITIONAL INVESTIGATION INTO THIS FEEDBACK INCLUDED A REVIEW OF THE PRODUCT LIABILITY CLAIM DETAILS. ALL OTHER COMMUNICATION AND INVESTIGATION INTO THIS REPORT/CLAIM IS BEING HANDLED BY OUR ATTORNEY. SUMMARY OF INVESTIGATION FINDINGS: A REVIEW OF THE DEVICE LOT HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE LOT PRODUCED A TOTAL OF 1 DEVICE. THE DEVICE LOT HISTORY RECORDS INDICATE THAT THE 1 DEVICE THAT WERE RELEASED FOR DISTRIBUTION MET THE FINAL INSPECTION SPECIFICATION REQUIREMENTS. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THE REPORTED LOT NUMBER. PER THE IFU, POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO: INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE OF TISSUE DEFECT. COMPLICATIONS, SUCH AS DELAYED WOUND INFECTION, HERNIA RECURRENCE, AND THE NEED FOR RE-OPERATION, SHOULD BE REASONABLY EXPECTED IN PATIENTS WHO ARE CRITICALLY ILL OR WHO HAVE SEVERELY CONTAMINATED ABDOMENS. BASED ON THE AVAILABLE DETAILS, A SPECIFIC CORRELATION BETWEEN THE DEVICE'S PERFORMANCE AND THE PATIENT'S OUTCOME ARE UNKNOWN. A ROOT CAUSE OF THE PATIENT'S EXPERIENCE IS INCONCLUSIVE DUE TO A LACK OF DETAILS. IF/WHEN ADDITIONAL INFORMATION IS OBTAINED, THAN THE COMPLAINT WILL BE REOPENED. UPDATE: BASED ON THE REVIEW OF MEDICAL RECORDS, THE PATIENT EXPERIENCED MULTIPLE RECURRENCES OF HERNIA REPAIR AND AN ABSCESS. THE ROOT CAUSE OF THE HERNIA RECURRENCE IS INCONCLUSIVE, BUT LIKELY DUE TO THE PATIENT'S COMPLEX HISTORY OF RECURRENT HERNIAS. THE CONTENTS OF THE ABSCESS WERE IDENTIFIED AS PROLENE SUTURE AND POLYPROPYLENE TYPE/SYNTHETIC MESH. PER THE MEDICAL RECORDS, THE SURGISIS WAS FIXED WITH VICRYL SUTURE. THE SURGISIS IS QUILTED WITH TRISORB SUTURE. THE CONTENTS OF THE ABSCESS APPEAR TO BE UNRELATED TO THE USE OF SURGISIS. UPDATE: BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE BIODESIGN HERNIA MESH'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. A ROOT CAUSE OF THE CLAIM ALLEGATIONS IS INCONCLUSIVE. HOWEVER, THE PRIOR ROOT CAUSE ANALYSIS (BASED ON THE REVIEW OF THE PATIENT'S MEDICAL RECORDS SUBMITTED TO CBI), REMAINS UNCHANGED AT THIS TIME. ALL OTHER MATTERS RELATING TO THIS LITIGATION ARE BEING HANDLED BY OUR ATTORNEY. IF/WHEN ADDITIONAL INFORMATION IS OBTAINED THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    A LAWYER CONTACTED COOK MEDICAL TO INFORM THEM OF A POTENTIAL PRODUCT LIABILITY CLAIM. PATIENT: (B)(6). LOT # - LB562350. (B)(6) 2022 - COOK LEGAL INDICATED NO ADDITIONAL DETAILS RECEIVED. (B)(6) 2022- COOK LEGAL INDICATED STILL NO ADDITIONAL DETAILS RECEIVED. UPDATE: THIS UPDATE WILL REFLECT MEDICAL RECORDS FINDINGS THAT APPEAR PERTINENT TO HERNIA REPAIR AND FACTORS THAT MAY PERTAIN TO THAT. MEDICAL RECORDS REVIEWED ARE IN THE ATTACHED FILES. PER MEDICAL RECORDS RECEIVED ON (B)(6) 2022: ON (B)(6) 2012, THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR WITH PARIETEX MESH. ON (B)(6) 2012, THE PATIENT UNDERWENT REPLACEMENT OF INFECTED AND REJECTED MESH AND SURGISIS HERNIA GRAFT WAS PLACED. ON (B)(6) 2013, THE PATIENT UNDERWENT ABDOMINAL WOUND EXPLORATION WITH DRAINAGE OF ABDOMINAL WALL ABSCESSES AND REMOVAL OF INFECTED MESH (PARTIAL). THE PATIENT WAS NOTED TO HAVE A RECURRENT HERNIA AND CHRONIC DISCHARGE FROM THE ABDOMINAL WOUND SINCE THE FIRST HERNIA REPAIR. SUTURES AND POLYPROPYLENE TYPE MESH WAS FOUND WITHIN THE ABSCESS. ON (B)(6) 2014, THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, RESECTION OF A LARGE HERNIA SAC, REPAIR OF VENTRAL HERNIA WITH COMPONENT SEPARATION AND STRATTICE MESH. A (B)(6) 2021 HISTORY AND PHYSICAL INDICATED THE PATIENT WAS WELL KNOWN TO THE SURGEON FOR MANY YEARS DUE TO RECURRENT VENTRAL INCISIONAL HERNIA IN HER RIGHT LOWER QUADRANT. PATIENT WAS SEEN DUE TO RECENT ER VISIT FOR BOWEL OBSTRUCTION. PER A CT SCAN, THE PATIENT HAS 1 LARGE HERNIA ON THE RIGHT AND THEN MULTIPLE OTHER HERNIAS AND POSSIBLE MIDLINE VENTRAL HERNIA WAS INCARCERATED AND WAS CAUSING SMALL-BOWEL OBSTRUCTION. PLAN WAS TO PROCEED WITH REPAIR. ON (B)(6) 2021, THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, EXTENSIVE LYSIS OF ADHESIONS, AND REPAIR OF MULTIPLE VENTRAL HERNIA INCISIONAL HERNIAS WITH MESH. SYMBOTEX COMPOSITE MESH WAS IMPLANTED. UPDATE: THIS UPDATE IS IN RELATION DETAILS PROVIDED IN A PRODUCT LIABILITY CLAIM PRESENTED TO CBI ON (B)(6) 2022. THE PATIENT WAS REPORTEDLY IMPLANTED WITH A BIODESIGN HERNIA MESH DEVICE, ON OR ABOUT (B)(6) 2012, AT ST. (B)(6) HEALTH SERVICES OF (B)(6). THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS PRODUCT BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MEDICAL TREATMENT. THE CLAIM REPORTS THAT AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2013, FOR A REVISION OPERATION WHEREIN THE BIODESIGN HERNIA MESH WAS FOUND TO BE CAUSING AND/OR CASUALLY CONTRIBUTING TO AN ABSCESS. ADDITIONALLY, THE CLAIM ALLEGES THAT THE BIODESIGN MESH HAD CAUSED A SEVERE INFLAMMATORY AND INFECTIOUS RESPONSE IN THE PATIENT WHICH NECESSITATED MESH REMOVAL SURGERY ALONG WITH REMOVAL AND DRAINAGE OF AN ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246082 BIODESIGN HERNIA GRAFT HERNIA GRAFT OXK COOK BIOTECH G36032 LB562350 10827002360324

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization