BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN 4-LAYER TISSUE GRAFT

    MDR report key: 3800406 · Received April 3, 2014

    Report

    Report Number
    1835959-2014-00083
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    July 23, 2009
    Report Date
    November 17, 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 COMMON NAME IS SURGICAL MESH, SOFT TISSUE PATCH / PRODUCT CODE IS FTM. UPDATE: A FOURTH DEGREE VAGINAL TEAR IS THE MOST SEVERE TYPE OF VAGINAL TEARS. THEY INVOLVE THE PERINEAL SKIN, VAGINAL MUCOSA, PERINEAL MUSCLES, THE ANAL SPHINCTER, AS WELL AS THE TISSUE LINING THE RECTUM. WITH THE DETAILS PROVIDED, IT IS BELIEVED THAT THE PATIENT¿S COMPLAINTS OF RECTOVAGINAL FISTULA, FECAL INCONTINENCE, AND PAINFUL SEX ARE DIRECTLY RELATED TO THE FOURTH-DEGREE TEAR SHE ACQUIRED DURING HER 2008 VAGINAL DELIVERY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNK AS LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT CATALOG NUMBER UNK AS PRODUCT UNSPECIFIED BY COMPLAINANT. SURGEON NAME NOT PROVIDED BY THE COMPLAINANT. IMPLANT DATE NOT PROVIDED BY THE COMPLAINANT. PRODUCT MANUFACTURE DATE UNK AS LOT NUMBER UNK. ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. INVESTIGATION INTO THIS CLAIM HAS INCLUDED A REVIEW OF THE CLAIM ALLEGATIONS, A REVIEW OF THE CLAIM ALLEGATIONS, A REVIEW OF 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 BIODESIGN OR SURGISIS 4-LAYER TISSUE GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNK. A ROOT CAUSE OF THE CLAIM 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 ADDITIONAL INFORMATION IS OBTAINED, THAT ALTERS OUR CONCLUSION TO THIS COMPLAINT, A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH BIODESIGN OR SURGISIS 4-LAYER TISSUE GRAFT ON (B)(6) 2008, AT (B)(6) MEDICAL CENTER, (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 PRODUCT BEING IMPLANTED IN THE PT, THE PT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE CORRECTIVE SURGERY. 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 PT STATUS.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH BIODESIGN OR SURGISIS 4-LAYER TISSUE GRAFT ON (B)(6) 2008, (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 CORRECTIVE SURGERY. UPDATE: THE PATIENT WAS IMPLANTED WITH A SURGISIS TISSUE GRAFT, ON (B)(6) 2008, (B)(6). THIS SURGERY WAS PERFORMED FOR REPAIR OF RECTOVAGINAL FISTULA WITH SURGISIS MESH INTERPOSITION. A POSTOPERATIVE VISIT WITH (B)(6) 2009 INDICATED THE PATIENT LOOKED WELL HEALED. OTHER POSTOPERATIVE VISITS, FOLLOWING THE SURGERY, INDICATED THAT THE PATIENT WAS STILL EXPERIENCING SOME STOOL IN THE VAGINA. THE PATIENT CONTINUED TO EXPERIENCE FECAL INCONTINENCE AND WAS REFERRED BY HER OBSTETRICIAN TO (B)(6). THE PATIENT WAS DIAGNOSED WITH PERSISTENT RECTOVAGINAL FISTULA AND THINNED SPHINCTER MUSCULATURE ANTERIORLY. THE PATIENT UNDERWENT A SPHINCTEROPLASTY AND REPAIR OF THE RECTOVAGINAL FISTULA ON (B)(6) 2009, PERFORMED BY (B)(6). IT IS UNCLEAR IF THE SURGISIS GRAFT WAS REMOVED DURING THIS SURGERY. THE PATIENT REPORTED FEELING AIR MOVE THROUGH HER VAGINA THE DAY AFTER THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200399 BIODESIGN 4-LAYER TISSUE GRAFT SURGISIS ES PAG COOK BIOTECH NA UNSPECIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability