BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - UNSPECIFIED BY THE COMPLAINANT

    MDR report key: 4093667 · Received September 4, 2014

    Report

    Report Number
    1835959-2014-00940
    Event Type
    Injury
    Date Received
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    PAG
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. PRODUCT NAME UNK, PRODUCT UNSPECIFIED. PRODUCT COMMON NAME UNK; PRODUCT UNSPECIFIED. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNK; LOT NUMBER NOT PROVIDED. PRODUCT CATALOG NUMBER UNK, PRODUCT UNSPECIFIED. A 510 (K) UNK; PRODUCT UNSPECIFIED. THE PRODUCT CODE LISTED IS NOT NECESSARILY THE PRODUCT CODE ASSIGNED TO THE DEVICE 510 (K), BUT RATHER THE PRODUCT CODE THAT SEEMS THE MOST APPROPRIATE BASED ON THE SURGICAL PROCEDURE IN WHICH THE PRODUCT WAS IMPLANTED. PRODUCT MFR DATE UNK; LOT NUMBER UNK. (B)(4). ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. OTHER REMARKS: INVESTIGATION INTO THIS CLAIM 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 INFO PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE SURGISIS BIOLOGICAL 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 ADD'L INFO IS OBTAINED A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH A SURGISIS BIOLOGICAL GRAFT ON (B)(6) 2010 AT (B)(6) HOSPITAL IN (B)(6), BY DR. (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 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
    541539 UNK - UNSPECIFIED BY THE COMPLAINANT UNK - PRODUCT UNSPECIFIED PAG COOK BIOTECH, INC. NA UNK

    Patients

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