BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN HIATAL HERNIA GRAFT

    MDR report key: 4203291 · Received October 23, 2014

    Report

    Report Number
    1835959-2014-00970
    Event Type
    Injury
    Date Received
    October 23, 2014
    Report Date
    October 23, 2014
    Manufacturer
    COOK BIOTECH INC
    Product Code
    PAI
    PMA / PMN Number
    K974540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. INVESTIGATION INTO THIS CLAIM HAS INCLUDED A REVIEW OF THE CLAIM ALLEGATIONS AND ALL OTHER COMMUNICATION AND INVESTIGATION INTO THIS REPORT/CLAIM IS BEING HANDLED BY OUR ATTORNEY. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE HIATAL HERNIA GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNK. A ROOT CAUSE OF THE CLAIM ALLEGATIONS IS INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. ALL OTHER MATTERS RELATING TO THIS LITIGATION ARE BEING HANDLED BY OUR ATTORNEY. IF/WHEN ADDITIONAL INFORMATION IS OBTAINED, THAT ALTERS OUR CONCLUSION TO THIS COMPLAINT, A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH AN ETHICON PROLIFT, AN ETHICON TVT-O, AND A SURGISIS ES ON OR ABOUT (B)(6) 2007 AND (B)(6) 2007 AT (B)(6). THE PT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS PRODUCT BEING IMPLANTED IN THE PT, THE PT HAS EXPERIENCED PAIN, INJURY AND HAS UNDERGONE MEDICAL TREATMENT. THE FOLLOWING INFORMATION WAS NOT PROVIDED BY THE COMPLAINANT: SPECIFIC INFORMATION OF THE ALLEGED INJURY, SPECIFIC INFORMATION REGARDING WHETHER INTERVENTION WAS PERFORMED, SPECIFIC INFORMATION 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. THE COMPLAINANT INDICATED THE COOK BIOTECH INC (CBI) MANUFACTURED PRODUCT TO BE A "SURGISIS ES, PRODUCT CODE C-PHR-7X10-U; LOT L8272278." A C-PHR-7X10-U GRAFT IS NOT LABELED AS A SURGISIS ES. ALSO, THE LOT L8272278 IS NOT A VALID CBI LOT NUMBER. HOWEVER, LB272278, IS A VALID CBI LOT NUMBER THAT DOES NOT COINCIDE WITH A SURGISIS ES, A C-PHR-7X10-U, NOR WAS THAT LOT SHIPPED TO MOBILE INFIRMARY IN (B)(4), AS INDICATED BY THE COMPLAINANT. ADDITIONALLY, THE COMPLAINANT LISTED 3 PRODUCTS AND TWO IMPLANT DATES, BUT DID NOT INDICATE WHICH PRODUCTS WERE IMPLANTED ON WHICH SPECIFIC DATE. AS SUCH, FOR PURPOSES OF FILING THIS MDR, THE COMPLAINT WILL BE FILED UNDER A C-PHR-7X10-U DEVICE. THE IMPLANT DATE REMAINS UNCLEAR AND WILL BE UPDATED WHEN ANY ADDITIONAL INFORMATION PROVIDES CLARITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677412 BIODESIGN HIATAL HERNIA GRAFT HIATAL HERNIA GRAFT PAI COOK BIOTECH INC N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability ETHICON TVT-0 810081, LOT 2980713| ETHICON PROLIFT TOTAL PFRT01 LOT 2987234