BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN SURGISIS ANTERIOR PELVIC FLOOR GRAFT

    MDR report key: 2921823 · Received January 14, 2013

    Report

    Report Number
    1835959-2013-00009
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    PMA / PMN Number
    K992159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF ALLEGED EVENTS NOT PROVIDED BY THE COMPLAINANTS. DEVICE EXPIRATION DATE UNKNOWN AS LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPLANTATION NOT CONFIRMED BY COMPLAINANT. DEVICE MANUFACTURE DATE NOT KNOWN AS LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. THIS MDR IS BEING FILED BEYOND THE 30-DAY REPORTING REQUIREMENT DUE TO OUR INITIAL ASSESSMENT RESULTING IN THE OPINION THAT THE COMPLAINT ALLEGATIONS ARISING FROM THIS LAWSUIT WERE TOO VAGUE AND NOT SPECIFIC ENOUGH TO FORM A CONCLUSIVE DECISION. AFTER FURTHER THOUGHT AND REVIEW, THE MDR IS BEING FILED. THUS FAR, INVESTIGATION INTO THIS CLAIM HAS INCLUDED: A REVIEW OF THE CLAIM ALLEGATIONS; A REVIEW OF THE (B)(4) COMPLAINT SYSTEM, WHICH DID NOT IDENTIFY ANY PREVIOUS COMPLAINTS MATCHING THE PROVIDED DETAILS; A SEARCH IN THE SHIPPING SYSTEM FROM (B)(4) 2009 TO (B)(4) 2010 INDICATED THAT J-PF-ANT HAS BEEN SHIPPED TO (B)(6) IN A TIME FRAME THAT WOULD CORRELATE WITH THE GIVEN SURGERY DATE; HOWEVER, A SPECIFIC LOT NUMBER COULD NOT BE IDENTIFIED, AS THERE HAVE BEEN MULTIPLE SHIPMENTS OF THE PRODUCT; AND REASSESSMENT OF THE (B)(4) IN WHICH A DETERMINATION TO FILE AN MDR WAS MADE; AND A REVIEW OF THE BIODESIGN SURGISIS ANTERIOR PELVIC FLOOR GRAFT IFU (B)(4). BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE BIODESIGN DEVICE PERFORMANCE AND THE ALLEGED INJURY REMAINS UNKNOWN. HOWEVER, BASED ON THE ALLEGATIONS IN THE COMPLAINT THAT, ON (B)(6) 2010, THE COMPLAINANT HAD IMPLANTED IN HER A PINNACLE ANTERIOR APICAL KIT DEVICE MANUFACTURED BY BOSTON SCIENTIFIC AND THEN HAD A BIODESIGN ANTERIOR PELVIC FLOOR GRAFT IMPLANTED ON (B)(6) 2010, WE SPECULATE THAT OUR PRODUCT WAS LIKELY PLACED TO REPAIR DAMAGE FROM THE PREVIOUSLY PLACED BOSTON SCIENTIFIC PRODUCT OR TO REPAIR A RECURRENCE OF THE PATIENT'S ORIGINAL PELVIC FLOOR DEFECT. THE BIODESIGN PELVIC FLOOR GRAFT IFU(B)(4) NOTES "THE FOLLOWING COMPLICATIONS ARE POSSIBLE WITH THE USE OF SURGICAL GRAFT MATERIALS: BLEEDING, INFECTION, ADHESIONS, STERILE EFFUSION, CHRONIC INFLAMMATION, ALLERGIC REACTION, DELAYED OR FAILED INCORPORATION OF GRAFT. IF CONDITIONS OF INFECTION, INFLAMMATION, OR ALLERGIC REACTION CANNOT BE RESOLVED, CONSIDER REMOVAL OF THE GRAFT." NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THE INVESTIGATION INTO THIS REPORT REMAINS ONGOING. IF/WHEN ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH A BOSTON SCIENTIFIC PINNACLE ANTERIOR APICAL KIT ON (B)(6) 2010. THE SURGERY WAS NOTED AS TAKING PLACE AT (B)(6) AND PERFORMED BY DR (B)(6). ON (B)(6) 2010, THE PATIENT WAS REPORTEDLY IMPLANTED WITH A COOK ANTERIOR PELVIC FLOOR GRAFT 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 INJURIES, PAIN, AND SUFFERING. 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 PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20916 BIODESIGN SURGISIS ANTERIOR PELVIC FLOOR GRAFT PELVIC FLOOR ANTERIOR FTM COOK BIOTECH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O| R (B)(6)| IMPLANTED:| BOSTON SCIENTIFIC PINNACLE ANTERIOR APICAL KIT| ((B)(4), LOT NUMBER 1ML0010801),