BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2334502 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00119
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    September 1, 2009
    Report Date
    October 7, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE UTI SYMPTOMS HAD RESOLVED. THE PATIENT REPORTING DEVELOPING URGE INCONTINENCE ON (B)(6) 2011 WHICH IS ONGOING. THE PATIENT WAS TREATED ON (B)(6) 2011 WITH A COMBINATION ANTICHOLINERGIC TREATMENT; OXYBUTININ AND HYOMAX. IF THIS TREATMENT FAILS HE WILL TREAT INJECT HER WITH INTRAVESICAL BOTOX INJECTIONS IN 3 - 4 WEEKS. THE EVENT WAS DETERMINED TO BE MILD IN SEVERITY AND NOT RELATED TO THE COAPTITE INJECTION. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT #1012833 MET ALL SPECIFICATIONS PRIOR TO RELEASE AND NO ABNORMALITIES WERE NOTED.

    Description of Event or Problem · 1

    A PATIENT (B)(6) WAS ENROLLED IN THE COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PATIENT WAS INJECTED WITH 1.0 ML OF COAPTITE ON (B)(6) 2009. THE PATIENT REPORTED A URINARY TRACT INFECTION ON (B)(6) 2010 WHICH WAS CONFIRMED WITH URINALYSIS TESTING. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE UTI RESOLVED ON (B)(6) 2010. THE PHYSICIAN ASSESSED THE EVENT AS MILD IN SEVERITY AND NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1012833

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention