BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN 4-LAYER TISSUE GRAFT

    MDR report key: 3800422 · Received April 3, 2014

    Report

    Report Number
    1835959-2014-00052
    Event Type
    Injury
    Date Received
    April 3, 2014
    Report Date
    January 27, 2016
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    PMA / PMN Number
    K980431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD/RESULTS - AS PRODUCT NOT RETURNED TO CBI. CONCLUSIONS - ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. THIS MDR IS RELATED TO MDR 1835959-2014-00053. 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 INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE SURGISIS 4-LAYER TISSUE GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. A ROOT CAUSE OF THE CLAIM ALLEGATIONS IS INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINT. ALL OTHER MATTERS RELATING TO THIS LITIGATION ARE BEING HANDLED BY OUR ATTORNEY. IF/WHEN ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. 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. THIS MDR IS RELATED TO MDR 1835959-2014-00053. UPDATE: THE ROOT CAUSE OF THE PATIENT¿S CURRENT COMPLAINTS IS INCONCLUSIVE. HOWEVER, THE PATIENT HAD URINARY INCONTINENCE AND FECAL INCONTINENCE PRIOR TO THE IMPLANTATION OF SURGISIS.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH A SURGISIS 4-LAYER TISSUE GRAFT ON (B)(6) 2009, BY DR. (B)(6), AT (B)(6) HOSPITAL. THE PT WAS IMPLANTED WITH A SURGISIS 4-LAYER TISSUE GRAFT ON (B)(6) 2011, BY DR (B)(6), AT (B)(6) HOSPITAL. THE PT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PT, THE PT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MEDICAL TREATMENT. THE FOLLOWING INFORMATION WAS NOT PROVIDED BY THE COMPLAINT: 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 PT STATUS.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH A SURGISIS 4-LAYER TISSUE GRAFT ON (B)(6) 2009, BY DR. (B)(6), AT (B)(6) HOSPITAL IN (B)(6). THE PATIENT WAS IMPLANTED WITH A SURGISIS 4-LAYER TISSUE GRAFT ON (B)(6) 2011, BY DR. (B)(6), AT (B)(6) HOSPITAL IN (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. UPDATE: ON (B)(6) 2009, DR. (B)(6) PERFORMED A RECTOCELE REPAIR WITH SURGISIS MESH. AT ONE WEEK POST OP THE PATIENT WAS SEEN WITH COMPLAINTS OF VAGINAL BLEEDING. THIS WAS NOTED AS NORMAL. THE PATIENT WAS SEEN AT SIX WEEKS POST OP WITH ABDOMINAL PAIN. THE VAGINAL BLEEDING HAD STOPPED. THE PATIENT WAS ADVISED TO REFRAIN FROM SEXUAL ACTIVITY AND RETURN FOR FOLLOW-UP IN SIX WEEKS. THE PATIENT RETURNED AS SCHEDULED AND HAD NO COMPLAINTS OF VAGINAL PAIN OR BLEEDING. HOWEVER THE PATIENT REPORTED SHE WAS ADVISED TO CONTINUE TO REFRAIN FROM SEXUAL ACTIVITY AS SHE WAS NOT HEALING AS EXPECTED. THE PATIENT WAS SEEN BY DR. (B)(6) WITH REPORTS OF DIFFICULTY WITH SEXUAL INTERCOURSE AND URINARY INCONTINENCE. THE PATIENT REPORTED THE INCONTINENCE ISSUE WAS THE SAME AS IT HAD BEEN PRIOR TO SURGERY. THE PATIENT HAD PALPABLE SUTURES IN THE VAGINAL CAVITY THAT WERE CAUSING DISCOMFORT TO HER SPOUSE DURING SEXUAL INTERCOURSE. THE PATIENT WAS SEEN BY DR. (B)(6) AND UNDERWENT A REVISION SURGERY ON (B)(6) 2011. DR. (B)(6) REMOVED A SUTURE AT THE VAGINAL APEX AND UTILIZED A 4-PLY SURGISIS GRAFT DURING THE SURGERY. THE PATIENT REPORTED THAT AFTER THIS SURGERY HER VAGINAL OPENING WAS SMALL DUE TO SCARRING. SHE WAS PRESCRIBED CREAM TO REDUCE PAIN AND DILATORS TO TRY TO STRETCH THE VAGINAL AREA. IN (B)(6) 2012, THE PATIENT WAS SEEN BY DR. (B)(6) AND WAS DIAGNOSED WITH VAGINAL STENOSIS AND VAGINAL PAIN. ON (B)(6) 2012, THE PATIENT UNDERWENT A SCAR REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200339 BIODESIGN 4-LAYER TISSUE GRAFT SURGISIS ES FTM COOK BIOTECH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability