BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN 4-LAYER TISSUE GRAFT

    MDR report key: 3893845 · Received June 12, 2014

    Report

    Report Number
    1835959-2014-00231
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 10, 2012
    Report Date
    November 23, 2015
    Manufacturer
    COOK BIOTECH
    Product Code
    PAG
    PMA / PMN Number
    K980431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EXPIRE DATE UNK; LOT NUMBER NOT PROVIDED. EC CONCLUSION CODE: 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 UNSPECIFIED SYMPHYSIS PELVIC FLOOR REPAIR GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNK. 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. IF/WHEN ADD'L INFO IS OBTAINED, A F/U MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMMON NAME IS SURGICAL MESH; LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED . PRODUCT CATALOG NUMBER UNKNOWN, PRODUCT UNSPECIFIED. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN. UPDATE: BASED ON A REVIEW OF THE ADDITIONAL DETAILS RECEIVED, THE PATIENT HAS A COMPLEX MEDICAL HISTORY RELATING TO HER GENITOURINARY ISSUES. A SPECIFIC CORRELATION BETWEEN THE SURGISIS 4-LAYER TISSUE GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. A ROOT CAUSE IS INCONCLUSIVE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH AN UNSPECIFIED SYMPHYSIS PELVIC FLOOR REPAIR GRAFT ON (B)(6) 2005, AT (B)(6). THE PT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCT 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 AN UNSPECIFIED SYMPHASIS PELVIC FLOOR REPAIR GRAFT ON (B)(6) 2005, AT (B)(6) HOSPITAL IN (B)(6), BY DR (B)(6). 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. UPDATE: ON (B)(6) 2005, THE PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED HYSTERECTOMY, ANTERIOR COLPHORRHAPHY WITH PARAVAGINAL REPAIR WITH GRAFTING (SURGISIS 4-LAYER TISSUE GRAFT), UTEROSACRAL VAULT SUSPENSION, LYSIS OF ADHESIONS, AND CYSTOSCOPY, PERFORMED BY DR (B)(6). THE PATIENT DEVELOPED AN INFECTION APPROXIMATELY ONE-WEEK POST OP RELATING TO A POSSIBLE ABSCESS IN HER PELVIC REGION. SHE WAS READMITTED TO THE HOSPITAL FOR IV ANTIBIOTICS AND HER SYMPTOMS RESOLVED. THE PATIENT'S GENITOURINARY SYMPTOMS HAD RESOLVED BY (B)(6) 2005. IN (B)(6) 2006, THE PATIENT'S PAIN RETURNED AND THE PATIENT BEGAN EXPERIENCING INCONTINENCE. THE PATIENT WAS SEEN BY DR (B)(6) TWICE A WEEK FOR HEPARIN INSTILLATIONS FOR RELIEF OF WHAT WAS BELIEVED TO BE RECURRENT INTERSTITIAL CYSTITIS. IN 2006, THE PATIENT WAS SEEN ONE TIME BY A UROLOGIST WITH COMPLAINTS OF VAGINAL, PELVIC, AND BLADDER PAIN. FROM 2006-2012 THE PATIENT WAS SEEN BY A PRIMARY CARE PHYSICIAN WHO PRESCRIBED THE PATIENT SLEEPING PILLS, PAIN KILLERS, HORMONES, AND ANTIBIOTICS. IN 2007, THE PATIENT WAS REFERRED TO A NEUROLOGIST SPECIALIZING IN BLADDER PROBLEMS. THE PATIENT DID NOT RETURN FOR THE RECOMMENDED TESTING. IN 2012, THE PATIENT WAS SEEN BY DR (B)(6), A RECONSTRUCTIVE UROLOGIST AT THE UNIVERSITY OF COLORADO HOSPITAL. ON (B)(6) 2012, THE PATIENT UNDERWENT A TRANSVAGINAL REMOVAL OF PRIOR PROSTHETIC GRAFT, IRRIGATION AND WASHOUT PROTOCOL, ANTERIOR REPAIR, A PUBOVAGINAL SLING UTILIZING AUTOLOGOUS RECTUS FASCIA, AND PLACEMENT OF SUPRAPUBIC CYSTOTOMY TUBE. THE PATIENT HAD RESOLUTION OF PAIN AFTER THIS SURGERY. HOWEVER, SHE CONTINUED TO HAVE URINARY VOIDING DIFFICULTIES. ON (B)(6) 2015, DR (B)(6) PLACED A PERCUTANEOUS NEUROSTIMULATOR FOR A DIAGNOSIS OF DETRUSOR-SPHINCTER DYSSYNERGIA (NEUROLOGICAL DISCONNECT BETWEEN THE BRAIN AND BLADDER THAT CAN LEAD TO URINARY DYSFUNCTION.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348638 BIODESIGN 4-LAYER TISSUE GRAFT SYMPHASIS PAG COOK BIOTECH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability