BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN URETHRAL SLING

    MDR report key: 3800449 · Received April 3, 2014

    Report

    Report Number
    1835959-2014-00042
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    April 10, 2005
    Report Date
    December 14, 2015
    Manufacturer
    COOK BIOTECH
    Product Code
    PAG
    PMA / PMN Number
    K992159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED. PRODUCT CATALOG NUMBER, PRODUCT UNSPECIFIED. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN. METHOD/RESULTS - AS PRODUCT NOT RETURNED TO CBI. 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 INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE BIODESIGN URETHRAL SLING'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.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH A STRATASIS URETHRAL SLING ON (B)(6) 2005, BY DR. (B)(6), AT (B)(6) MEDICAL CENTER IN (B)(6). 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 STRATASIS URETHRAL SLING ON (B)(6) 2005, BY DR. (B)(6), AT (B)(6) MEDICAL CENTER IN (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. BE FILED. UPDATE: ON 03/18/2005, THE PATIENT UNDERWENT A CYSTOCELE REPAIR AND PLACEMENT OF A STRATASIS URETHRAL SLING FOR REPAIR OF STRESS URINARY INCONTINENCE. APPROXIMATELY ONE WEEK POST SURGERY, THE PATIENT EXPERIENCED ABDOMINAL PAIN, VAGINAL PAIN, FEVER, BODY ACHES, AND A PURULENT VAGINAL DISCHARGE. THE PATIENT SAW DR. BURTON AT APPROXIMATELY TWO (2) WEEKS POST OP. THE PATIENT THEN PRESENTED TO THE EMERGENCY ROOM AT (B)(6) MEMORIAL HOSPITAL ON (B)(6) 2005 WITH INCREASED PAIN, NAUSEA, AND DIZZINESS. THE PATIENT HAD AN ABSCESS IN HER RIGHT INGUINAL AREA. INCISION AND DRAINAGE WAS PERFORMED, ON (B)(6) 2005, AND A DRAIN WAS PLACED. THE PATIENT WAS HOSPITALIZED AND RECEIVED IV ANTIBIOTICS AND PAIN MEDICATION. SHE WAS DISCHARGED ON (B)(6) 2005 WITH ORAL ANTIBIOTICS AND PAIN MEDICATION. ON (B)(6) 2005, THE PATIENT WAS SEEN IN FOLLOW-UP AND WAS REPORTEDLY DOING WELL AND THERE WAS NO RECURRENT INFECTION PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200727 BIODESIGN URETHRAL SLING URETHRAL SLING PAG COOK BIOTECH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability