BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2334556 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00136
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    July 17, 2008
    Report Date
    October 7, 2011
    Manufacturer
    MERZ AESTHETICS, INC
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED IN THE INTERIM POST-APPROVAL STUDY STATUS REPORT FOR PMA P040047, (B)(6) 2011. ON (B)(6) 2008, A CYSTOSCOPY WAS PERFORMED AND DID NOT SHOW ANY EVIDENCE OF TISSUE EROSION, NO EVIDENCE OF DISSECTION AND NO EVIDENCE OF ANY OTHER COAPTITE ADVERSE EVENT.

    Description of Event or Problem · 1

    A PT (B)(6), WAS ENROLLED IN THE COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PT HAD NO PRIOR SURGERIES FOR INCONTINENCE. THE PT WAS INJECTED ON (B)(6)2008 WITH 0.7ML OF COAPTITE. ON (B)(6) 2008 THE PT CAME INTO THE PHYSICIAN'S OFFICE. A URINALYSIS WAS PERFORMED. THE CULTURE WAS POSITIVE AND THE PT WAS PRESCRIBED CIPRO, 250MG FOR 5 DAYS. A CYSTOSCOPY WAS PERFORMED, NO ISSUES WERE REPORTED. THE PT RETURNED ON (B)(6) 2008 AND A CYSTOSCOPY WAS PERFORMED THAT DID NOT SHOW ANY EVIDENCE OF TISSUE EROSION OR ANY EVIDENCE OF DISSECTION. ON (B)(6) 2008, THE PT WAS GIVEN AN ADDITIONAL INJECTION OF 1.0ML OF COAPTITE. ON (B)(6) 2008 A REPEAT URINALYSIS WAS PERFORMED WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention