BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN HIATAL HERNIA GRAFT

    MDR report key: 5691159 · Received June 1, 2016

    Report

    Report Number
    1835959-2016-00135
    Event Type
    Injury
    Date Received
    June 1, 2016
    Report Date
    May 31, 2016
    Manufacturer
    COOK BIOTECH
    Product Code
    OWV
    PMA / PMN Number
    K133011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED . PRODUCT CATALOG NUMBER UNKNOWN, PRODUCT UNSPECIFIED . PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE BIODESIGN HIATAL HERNIA GRAFT¿S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. A ROOT CAUSE OF THE CLAIM ALLEGATIONS IS INCONCLUSIVE DUE TO THE LACK OF DETAILS PROVIDED BY THE COMPLAINANT. ALL OTHER MATTERS RELATING TO THIS LITIGATION ARE BEING HANDLED BY OUR ATTORNEY. A FOLLOW-UP MDR WILL BE FILED IF ADDITIONAL DETAILS ARE OBTAINED.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH A BIODESIGN HIATAL HERNIA GRAFT ON (B)(6) 2012, AT (B)(6) HOSPITAL (B)(6) IN (B)(6), BY DR. (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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348073 BIODESIGN HIATAL HERNIA GRAFT HIATAL HERNIA GRAFT OWV COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability NONE REPORTED BY THE COMPLAINANT.