BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN - UNSPECIFIED BY THE COMPLAINT

    MDR report key: 3800382 · Received April 3, 2014

    Report

    Report Number
    1835959-2014-00089
    Event Type
    Injury
    Date Received
    April 3, 2014
    Report Date
    April 2, 2014
    Manufacturer
    COOK BIOTECH INCORPORATED
    Product Code
    FTM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. ADDITIONAL DEVICE INFO: PRODUCT NAME UNK; PRODUCT UNSPECIFIED. PRODUCT COMMON NAME UNK; PRODUCT UNSPECIFIED. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNK AS LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT CATALOG NUMBER UNK AS PRODUCT UNSPECIFIED BY COMPLAINANT. SURGEON NAME NOT PROVIDED BY THE COMPLAINANT. IMPLANT DATE NOT PROVIDED BY THE COMPLAINANT. PMA/510(K): 510K UNK; PRODUCT UNSPECIFIED. THE PRODUCT CODE LISTED IS NOT NECESSARILY THE PRODUCT CODE ASSIGNED TO THE DEVICE 510K, BUT RATHER THE PRODUCT CODE THAT SEEMS THE MOST APPROPRIATE BASED ON THE SURGICAL PROCEDURE IN WHICH THE PRODUCT WAS IMPLANTED. PRODUCT MANUFACTURE DATE UNK AS LOT NUMBER UNK. ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. MDR RELATED TO MDR #1835959-2014-00088. INVESTIGATION INTO THIS CLAIM HAS INCLUDED A REVIEW OF THE CLAIM ALLEGATIONS, A REVIEW OF THE CLAIM ALLEGATIONS,A REVIEW OF 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 UNSPECIFIED COOK PELVIC FLOOR REPAIR PRODUCT'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 UNSPECIFIED COOK PELVIC FLOOR REPAIR PRODUCT ON (B)(6) 2010, AT (B)(6) BY (B)(6) TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. 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 CORRECTIVE SURGERY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200364 UNKNOWN - UNSPECIFIED BY THE COMPLAINT UNKNOWN - PRODUCT UNSPECIFIED FTM COOK BIOTECH INCORPORATED NA UNSPECIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability PINNACLE PELVIC FLOOR REPAIR KIT AND A BARD ALIGN| RETROPUBIC URETHRAL SUPPORT SYSTEM| ADDITIONAL PINNACLE PELVIC FLOOR REPAIR KIT