BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT

    MDR report key: 2921826 · Received January 14, 2013

    Report

    Report Number
    1835959-2013-00008
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    January 14, 2013
    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 ALLEGED EVENTS NOT PROVIDED BY THE COMPLAINANTS. DEVICE EXP DATE NOT KNOWN AS LOT NUMBER NOT PROVIDED BY COMPLAINANT. SURGEON NAME NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPLANTATION NOT CONFIRMED BY COMPLAINANT. DEVICE MFR DATE NOT KNOWN AS LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. THIS MDR IS BEING FILED BEYOND THE 30-DAY REPORTING REQUIREMENT DUE TO OUR INITIAL ASSESSMENT RESULTING IN THE OPINION THAT THE COMPLAINT ALLEGATIONS ARISING FROM THIS LAWSUIT WERE TOO VAGUE AND NOT SPECIFIC ENOUGH TO FORM A CONCLUSIVE DECISION. AFTER FURTHER THOUGHT AND REVIEW, THIS MDR IS BEING FILED. THUS FAR, INVESTIGATION INTO THIS CLAIM HAS INCLUDED: A REVIEW OF THE CLAIM ALLEGATIONS; A REVIEW OF THE CBI COMPLAINT SYSTEM WHICH DID NOT IDENTIFY ANY PREVIOUS COMPLAINTS MATCHING THE PROVIDED DETAILS; A SEARCH OF THE SHIPPING SYSTEM INDICATED THAT (B)(4) HAS BEEN SHIPPED TO (B)(6) MED CTR IN A TIME FRAME THAT WOULD CORRELATE WITH THE GIVEN SURGERY DATE; HOWEVER, A SPECIFIC LOT NUMBER COULD NOT BE IDENTIFIED AS THERE HAVE BEEN MULTIPLE SHIPMENTS OF THE PRODUCT. REASSESSMENT OF THE AE REPORTING DECISION TREE IN WHICH A DETERMINATION TO FILE AN MDR WAS MADE; AND A REVIEW OF THE BIODESIGN SURGISIS TISSUE GRAFT IFU FP0005-4F. THE BIODESIGN SURGISIS TISSUE GRAFT IFU FP0005-4F NOTES THAT "THE FOLLOWING COMPLICATIONS ARE POSSIBLE WITH THE USE OF SURGICAL GRAFT MATERIALS. IF ANY OF THESE CONDITIONS OCCUR, THE GRAFT SHOULD BE REMOVED: INFECTION, ACUTE OR CHRONIC INFLAMMATION (INITIAL APPLICATION OF SURGICAL GRAFT MATERIALS MAY BE ASSOCIATED WITH TRANSIENT, MILD, LOCALIZED INFLAMMATION), ALLERGIC REACTION, AND SEROMA FORMATION." NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THE INVESTIGATION INTO THIS REPORT REMAINS ONGOING. IF/WHEN ADDITIONAL INFO IS OBTAINED A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH THE SURGISIS BIODESIGN 4-LAYER TISSUE GRAFT TO TREAT HER STRESS URINARY INCONTINENCE. THE SURGERY WAS NOTED AS TAKING PLACE AT (B)(6) MED CTR. 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. 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
    20917 BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT 4-LAYER TISSUE GRAFT FTM COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O| S NOT APPLICABLE, NONE REPORTED BY THE COMPLAINANT.