BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2334533 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00120
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    September 22, 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. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THE REPORTED LOT #1011177 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 (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. THE PATIENT WAS INJECTED WITH 2.0 ML OF COAPTITE ON (B)(6) 2009. THE PATIENT REPORTED A URINARY TRACT INFECTION ON (B)(6) 2011 WHICH WAS CONFIRMED BY URINALYSIS TESTING. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE UTI RESOLVED ON (B)(6) 2011. THE PHYSICIAN ASSESSED THE EVENT AS MILD IN SEVERITY AND WAS NOT RELATED TO THE COAPTITE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1011177

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention DETROL LA, 4 MG