BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN POSTERIOR PELVIC FLOOR GRAFT

    MDR report key: 5516349 · Received March 22, 2016

    Report

    Report Number
    1835959-2016-00028
    Event Type
    Injury
    Date Received
    March 22, 2016
    Report Date
    March 21, 2016
    Manufacturer
    COOK BIOTECH
    Product Code
    PAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMMON NAME UNKNOWN; PRODUCT UNSPECIFIED - PRODUCT CODE PAG / PAI. CONCOMITANT PRODUCTS - BARD ALIGN URETHRAL SUPPORT SYSTEM ON (B)(6) 2009; BARD AVAULTA SOLO POSTERIOR SYNTHETIC SUPPORT SYSTEM ON (B)(6) 2009; NEOMEDIC REMEEX SYSTEM ON (B)(6) 2013. AS REQUESTED BY THE FDA, WE HAVE MADE NOTE OF THE PRODUCT CODE. 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. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE BIODESIGN OR SURGISIS POSTERIOR PELVIC FLOOR 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 BARD ALIGN URETHRAL SUPPORT SYSTEM AND A BARD AVAULTA SOLO POSTERIOR SYNTHETIC SUPPORT SYSTEM ON (B)(6) 2009, AT (B)(6), BY DR. (B)(6). ADDITIONALLY, THE PATIENT WAS REPORTEDLY IMPLANTED WITH A BIODESIGN OR SURGISIS POSTERIOR PELVIC FLOOR GRAFT AND A NEOMEDIC REMEEX SYSTEM ON (B)(6) 2013 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
    174403 BIODESIGN POSTERIOR PELVIC FLOOR GRAFT PAI COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability