BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 3080003 · Received April 24, 2013

    Report

    Report Number
    1835959-2013-00035
    Event Type
    Injury
    Date Received
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE NOT PROVIDED BY THE COMPLAINANT. PRODUCT BRAND NAME UNK AS COMPLAINANT DID NOT SPECIFY IF THE SIS SLING WAS THE TENSION-FREE URETHRAL SLING OR THE URETHRAL SLING. PRODUCT COMMON NAME UNK AS COMPLAINANT DID NOT SPECIFY IF THE SIS SLING WAS THE TENSION-FREE URETHRAL SLING OR THE URETHRAL SLING. LOT NUMBER AND EXPIRATION DATE NOT PROVIDED BY THE COMPLAINANT. IMPLANT DATE NOT PROVIDED BY THE COMPLAINANT. PRODUCT 510(K) UNK AS COMPLAINANT DID NOT SPECIFY IF THE SIS SLING WAS THE TENSION-FREE URETHRAL SLING OR THE URETHRAL SLING. MFR DATE UNK AS LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. CONCLUSIONS: 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 CBI COMPLAINT SYSTEM, AND ALL OTHER COMMUNICATION AND INVESTIGATION INTO THIS REPORT/CLAIM WAS HANDLED BY OUR ATTORNEY. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE SIS SLING'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 A SIS SLING AND AN IN-FAST SLING, DURING SURGERY PERFORMED AT (B)(6) HOSPITAL TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177528 NONE FTM COOK BIOTECH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability THE CLAIM INDICATES AN IN-FAST SLING WAS USED IN| ADDITION TO THE SIS SLING. NO SURGERY DATE WAS| PLACED AT ONCE OR ON SEPARATE SURGERY DATES| PROVIDED SO IT IS UNCLEAR IF BOTH PRODUCTS WERE