BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 4223995 · Received October 29, 2014

    Report

    Report Number
    2135225-2014-00083
    Event Type
    Other
    Date Received
    October 29, 2014
    Date of Event
    February 12, 2012
    Report Date
    October 1, 2014
    Manufacturer
    MERZ NORTH AMERICA. 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

    (B)(4). AT THE TIME OF REPORT WAS RECEIVED, THE PT'S URINARY TRACT INFECTION HAD RESOLVED. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WAS REVIEWED. ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE WITH NO ANOMALIES NOTED.

    Description of Event or Problem · 1

    A PT, IW ((B)(6)) WAS ENROLLED IN THE COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED WITH 1.0 ML OF COAPTITE LOT #1027423 ON (B)(6) 2012. THE PT REPORTED A URINARY TRACT INFECTION ON (B)(6) 2012. THE PT WAS TREATED WITH ANTIBIOTIC, CIPRO X 10 DAYS STARTING (B)(6) 2012. THE INFECTION RESOLVED ON (B)(6) 2012. THE PHYSICIAN ASSESSED THE EVENT AS MILD IN SEVERITY AND DEFINITELY NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692795 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA. INC. 1027423

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention OXYBUTININ 10MG| SANCTRA XR 60MG