BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN 4-LAYER TISSUE GRAFT

    MDR report key: 3682998 · Received February 24, 2014

    Report

    Report Number
    1835959-2014-00007
    Event Type
    Injury
    Date Received
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    PMA / PMN Number
    K980431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. METHODS: NO TESTING METHODS PERFORMED AS PRODUCT NOT RETURNED TO CBI. CONCLUSIONS - ROOT CAUSE RELATED TO USE OF ANOTHER MFR'S DEVICE. THIS MDR IS RELATED TO MDR 1835959-2013-02138. INVESTIGATION EVAL: INVESTIGATION INTO THIS CLAIM INCLUDED A REVIEW OF THE CLAIM ALLEGATIONS; A REVIEW OF THE CBI COMPLAINT SYSTEM; A REVIEW OF THE DEVICE HISTORY RECORDS WHICH INDICATED THE PRODUCT WAS MFG TO SPECS; A REVIEW OF THE BIODESIGN 4-LAYER TISSUE GRAFT IFU FP0005-4D, AND ALL OTHER COMMUNICATION AND INVESTIGATION INTO THIS REPORT/CLAIM IS BEING HANDLED BY OUR ATTORNEY. SUMMARY OF INVESTIGATION FINDINGS: A REVIEW OF MEDICAL RECORDS INDICATED THAT THE COOK BIOTECH INC MFG DEVICE PLACED IN THE PT WAS ACTUALLY A BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT ON (B)(6) 2011 AND NOT THE SURGISIS BIODESIGN TENSION-FREE SLING ON (B)(6) 2009 AS ORIGINALLY NOTED BY THE COMPLAINANT. THE DEVICE PLACED IN THE PT ON (B)(6) 2009 WAS NOT A COOK BIOTECH INC MFG DEVICE, BUT RATHER AN AMS MFG DEVICE. AFTER REVIEWING THE ADDITIONAL DETAILS RECEIVED, IT DOES NOT APPEAR THAT THE BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT CAUSED OR CONTRIBUTED TO ANY LIFE THREATENING ILLNESS OR INJURY, PERMANENT IMPAIRMENT OR DAMAGE, NOR DID THE PT REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SERIOUS INJURY OR DEATH AS A RESULT OF THE GRAFT BEING PLACED. THE PT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT BEING PLACED THAT SHOULD THEY RECUR WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH, SERIOUS INJURY, OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SERIOUS INJURY OR DEATH. THE BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT WAS PLACED TO REPAIR A DEFECT THAT WAS LEFT AFTER EXCISION OF THE ERODED AMS MESH. THE ROOT CAUSE OF THE PT'S ALLEGATIONS APPEARS TO BE RELATED TO USE OF ANOTHER MFR'S DEVICE. ALL OTHER MATTERS RELATING TO THIS LITIGATION ARE BEING HANDLED BY OUR ATTORNEY. IF/WHEN ADDITIONAL INFO IS OBTAINED, A F/U MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH A SURGISIS BIODESIGN TENSION-FREE URETHRAL SLING ON (B)(6) 2009 AND AN AMS MINIARC SLING ON (B)(6) 2010, AT TRINITY HOSPITAL IN (B)(6), TO TREAT HER STRESS URINARY INCONTINENCE. THE PT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PT, THE PT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE CORRECTIVE SURGERY. A REVIEW OF MEDICAL RECORDS INDICATED THAT ON (B)(6) 2010, THE PT UNDERWENT A DIAGNOSTIC LAPAROSCOPY WITH LYSIS OF OMENTAL ADHESIONS, INCIDENTAL APPENDECTOMY, MESH (AMS) EXCISION WITH REPAIR WITH A SURGISIS BIODESIGN VAGINAL EROSION REPAIR GRAFT, AND A CYSTOSCOPY, PERFORMED BY (B)(6), MD AT (B)(6) HOSPITAL OF (B)(6), FOR THE TREATMENT AND EXPLORATION OF HER RIGHT LOWER QUADRANT PAIN, SUBURETHRAL MESH EROSION, CHRONIC NAUSEA, AND INTERMITTENT FEVER OF UNK ORIGIN. ON (B)(6) 2011, THE PT UNDERWENT A CYSTOSCOPY, EXCISION OF FRAGMENTS OF RIGHT AND LEFT PERIURETHRAL MESH (AMS) WITH BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT BRIDGING, AND A POST PROCEDURE CYSTOSCOPY, PERFORMED BY (B)(6), MD AT (B)(6) HOSPITAL OF (B)(6), FOR THE TREATMENT OF HER DYSPAREUNIA, VAGINAL BLEEDING, RIGHT LOWER QUADRANT PAIN, AND ATROPHIC VAGINITIS. THE FOLLOWING INFO WAS NOT PROVIDED BY THE COMPLAINANT: SPECIFIC INFO OF THE ALLEGED INJURY; SPECIFIC INFO REGARDING WHETHER INTERVENTION WAS PERFORMED; SPECIFIC INFO REGARDING WHY INTERVENTION WAS PERFORMED OR WHAT TYPE/TO WHAT EXTENT INTERVENTION WAS PERFORMED; SPECIFIC CORRELATION BETWEEN DEVICE PERFORMANCE AND ALLEGED INJURY; CURRENT PT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112918 BIODESIGN 4-LAYER TISSUE GRAFT SURGISIS ES FTM COOK BIOTECH LB519324

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability AMS MINIARC SLING TVT-O, LOT# 811449048