BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN SURGISIS URETHRAL SLING

    MDR report key: 2921818 · Received January 14, 2013

    Report

    Report Number
    1835959-2013-00004
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    PMA / PMN Number
    K992159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF ALLEGED EVENTS NOT PROVIDED BY THE COMPLAINANTS. PRODUCT EXPLANTATION NOT CONFIRMED BY COMPLAINANT. THIS MDR IS BEING FILED BEYOND THE 30-DAY REPORTING REQUIREMENT DUE TO OUR INITIAL ASSESSMENT RESULTING IN THE OPINION THAT THE COMPLAINT ALLEGATIONS ARISING FROM THIS LAWSUIT WERE TOO VAGUE AND NOT SPECIFIC ENOUGH TO FORM A CONCLUSIVE DECISION. AFTER FURTHER THOUGHT AND REVIEW, THE MDR IS BEING FILE. THUS FAR, INVESTIGATION INTO THIS CLAIM HAS INCLUDED A REVIEW OF THE CLAIM ALLEGATIONS, A REVIEW OF THE CBI COMPLAINT SYSTEM WHICH DID NOT IDENTIFY ANY PREVIOUS COMPLAINTS MATCHING THE PROVIDED DETAILS, A SEARCH IN THE SHIPPING SYSTEM FROM 2006 TO PRESENT INDICATED THAT (B)(4) HAS BEEN SHIPPED TO ERLANGER MEDICAL CENTER; HOWEVER, A SPECIFIC LOT NUMBER COULD NOT BE IDENTIFIED AS THERE HAVE BEEN MULTIPLE SHIPMENTS OF THE PRODUCT, REASSESSMENT OF THE AE REPORTING DECISION TREE IN WHICH A DETERMINATION OF FILE AN MDR WAS MADE, INCIDENT INVESTIGATION COMMITTEE DISCUSSED APPROPRIATE WORDING FOR AN MDR SUBMISSION GIVEN THE VAGUE DETAILS OF THE CLAIM, AND A REVIEW OF THE STRATASIS URETHRAL SLING IFU FP0007-2A. THE STRATASIS URETHRAL SLING IFU FP0007-2A NOTES THAT "THE FOLLOWING COMPLICATIONS ARE POSSIBLE WITH THE USE OF SURGICAL GRAFT MATERIALS. IF ANY OF THESE CONDITIONS OCCUR, THE DEVICE SHOULD BE REMOVED. INFECTION, ACTUTE OR CHRONIC INFLAMMATION (INITIAL APPLICATION OF SURGICAL GRAFT MATERIALS MAY BE ASSOCIATED WITH TRANSIENT, MILD, LOCALIZED INFLAMMATION.), AND ALLERGIC REACTION." NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THE INVESTIGATION INTO THIS REPORT REMAINS ONGOING. IF/WHEN ADDITIONAL INFORMATION IS OBTAINED A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH THE STRATASIS TENSION-FREE URETHRAL SLING TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. RECEIVED OPERATIVE REPORTS INDICATE THE SURGERY TOOK PLACE AT (B)(6) HEALTH SYSTEM ON (B)(6) 2002 AND WAS PERFORMED BY DR. MICHAEL BREEN. IN ADDITION ON (B)(6) 2002, DR (B)(6) PERFORMED AN ANTERIOR AND POSTERIOR COLPORRHAPHY, CYSTOSCOPY, AND SUPRAPUBIC CATHETER PLACEMENT. 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. 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 PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20416 BIODESIGN SURGISIS URETHRAL SLING URETHRAL SLING FTM COOK BIOTECH SB102859

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S 37179 LOT 4372749| MICROVASIVE PRECISION TWIST ANCHOR SYSTEM| IMPLANTED