BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3193559 · Received June 25, 2013

    Report

    Report Number
    1835959-2013-00046
    Event Type
    Injury
    Date Received
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    COOK BIOTECH
    Product Code
    PAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE NOT PROVIDED BY THE COMPLAINANT. PRODUCT NAME NOT PROVIDED BY THE COMPLAINANT. PRODUCT COMMON NAME NOT KNOWN DUE TO PRODUCT UNSPECIFIED BY THE COMPLAINANT. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNK AS LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. SURGEON NAME NOT PROVIDED BY THE COMPLAINANT. PMA/510(K) UNK AS PRODUCT WAS UNSPECIFIED BY THE COMPLAINANT. PRODUCT MFR DATE UNK AS LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. LIKELY CAUSED BY ANOTHER DEVICE NOT MANUFACTURED AT COOK BIOTECH INC. 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 IS BEING HANDLED BY AN ATTORNEY. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE UNSPECIFIED SURGISIS BIODESIGN 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 REPORTEDLY IMPLANTED WITH A BARD SLING URETEX AND COLLAGEN PELVICOL DURING SURGERY PERFORMED AT (B)(6) MEDICAL CENTER ON (B)(6) 2004; AN UNSPECIFIED SURGISIS BIODESIGN GRAFT AT (B)(6) MEDICAL CENTER ON (B)(6) 2008; AND AN AMS INTEPRO LPP Y-SLING AND SPARC AT (B)(6) HOSPITAL ON (B)(6) 2012. THESE PRODUCTS WERE PLACED IN THE PT TO TREAT HER VAGINAL VAULT PROLAPSE AND STRESS URINARY INCONTINENCE. THE PT AND HER ATTORNEY ALLEGED THAT AS A RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PT, THE PT HAS EXPERIENCED PAIN AND 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
    287283 UNK NONE PAJ COOK BIOTECH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability SPARC,| A BARD SLING URETEX,| THE PT WAS REPORTEDLY IMPLANTED WITH A,| AMS INTEPRO LPP Y-SLING,| COLLAGEN PELVICOL,