BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN 8-LAYER TISSUE GRAFT

    MDR report key: 3800384 · Received April 3, 2014

    Report

    Report Number
    1835959-2014-00099
    Event Type
    Injury
    Date Received
    April 3, 2014
    Report Date
    February 8, 2016
    Manufacturer
    COOK BIOTECH
    Product Code
    PAG
    PMA / PMN Number
    K992159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE PATIENT¿S RECURRENT PROLAPSE AND PELVIC ISSUES IS INCONCLUSIVE. HOWEVER, LACK OF EFFECTIVENESS AND RECURRENCE ARE KNOWN POTENTIAL OUTCOMES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT; PRODUCT EXPIRE DATE UNK; LOT NUMBER NOT PROVIDED. PRODUCT MFR DATE UNK; LOT NUMBER UNK. CONCLUSIONS: ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. 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 SYMPHASIS GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNK. A ROOT CAUSE OF THE CLAIMS 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 SYMPHASIS GRAFT ON (B)(6) 2005, AT (B)(6) MEDICAL CENTER IN (B)(6) BY (B)(6), M.D. TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. THE PT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS/THESE PRODUCT(S) 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.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH A SYMPHASIS GRAFT ON (B)(6) 2005, AT (B)(6) BY (B)(6) TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS PRODUCT BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MEDICAL TREATMENT. ON (B)(6) 2005, DR. (B)(6) PERFORMED A LAPAROTOMY, CLOSURE OF PELVIC FASCIAL DEFECT WITH A SYMPHASIS GRAFT, AND A VAGINAL VAULT SUSPENSION, FOR REPAIR OF THE PATIENT'S RECURRENT CYSTOCELE WITH TRANSVERSE DEFECT. THE PATIENT REPORTED THE PROLAPSE RECURRED APPROXIMATELY EIGHT TO NINE MONTHS AFTER THIS SURGERY. SHE ALSO REPORTED EXPERIENCING PELVIC PAIN, WHICH OCCURRED MORE FREQUENTLY, VAGINAL CRAMPING, AND DYSPAREUNIA. ON (B)(6) 2013, DR. (B)(6) PERFORMED AN EXCISION OF PREVIOUS BIOLOGIC GRAFT MATERIAL, A FOUR-WALL SACROSPINOUS LIGAMENT SUSPENSION, AN ANTERIOR COLPORRHAPHY, A CYSTOSCOPY, AND REMOVAL OF MULTIPLE SUTURES FOR REPAIR OF THE PATIENT'S RECURRENT VAGINAL BULGE. THE PATIENT REPORTED HER SYMPTOMS RESOLVED AFTER THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200537 BIODESIGN 8-LAYER TISSUE GRAFT SYMPHASIS PAG COOK BIOTECH NA UNSPECIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability