BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGISIS

    MDR report key: 5575947 · Received April 14, 2016

    Report

    Report Number
    1835959-2016-00051
    Event Type
    Injury
    Date Received
    April 14, 2016
    Report Date
    April 11, 2016
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. PRODUCT COMMON NAME UNKNOWN; PRODUCT UNSPECIFIED; PRODUCT CODE PAG / PAI. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED. PRODUCT CATALOG NUMBER UNKNOWN, PRODUCT UNSPECIFIED. CONCOMITANT MEDICAL PRODUCTS: (B)(4) PROLIFT+M ON (B)(6) 2010; (B)(4) TVT-OBTURATOR ON (B)(6) 2010. 510(K) UNKNOWN; 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 MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE UNSPECIFIED (B)(4) PRODUCT¿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 AN (B)(4) PROLIFT+M, AN (B)(4) TVT-OBTURATOR, AND AN UNSPECIFIED (B)(4) PRODUCT ON (B)(6) 2010, AT (B)(6), BY DR. (B)(6). THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCTS 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
    233796 SURGISIS FTM COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability