BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 2803337 · Received October 17, 2012

    Report

    Report Number
    2135225-2012-00145
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    August 11, 2009
    Report Date
    September 17, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR LOTS: 1009652 (EXPIRATION DATE 05/2011, MANUFACTURED 05/2008), 1013181 (EXPIRATION DATE 04/2012, MANUFACTURED 04/2009), 1012959 (EXPIRATION DATE 04/2012, MANUFACTURED 04/2009) AND 1013660 (EXPIRATION DATE 06/2012, MANUFACTURED 2009) WERE REVIEWED, ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PATIENT (B)(6) WAS ENROLLED IN THE (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2009, THE PATIENT WAS INJECTED WITH 2.0 ML COAPTITE, LOTS 1010293 AND 1009652. ON (B)(6) 2009, THE PATIENT WAS INJECTED WITH 1.6 ML COAPTITE, LOTS 1013181 AND 1012959. ON (B)(6) 2009, THE PATIENT WAS INJECTED WITH 2.0 ML COAPTITE, LOT 1013660. ON (B)(6) 2009, THE PATIENT DEVELOPED EXTRAVASATION DURING INJECTION DIAGNOSED BY CYTOSCOPY; 0.4 ML EXTRAVASATED. THE PATIENT WAS NOT TREATED AND RECOVERED ON THE SAME DAY. PER PHYSICIAN, THE EVENT WAS OF MILD SEVERITY AND DEFINITELY NOT RELATED TO COAPTITE. ON (B)(6) 2011, THE PATIENT DEVELOPED URINARY TRACT INFECTION DIAGNOSED BY URINALYSIS. THE PATIENT WAS TREATED WITH MICROBID 100 MG BID X 7 DAYS AND RECOVERED ON (B)(6) 2011. PER PHYSICIAN, THE EVENT WAS OF MILD SEVERITY AND PROBABLY NOT RELATED TO COAPTITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1010293

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention VESICARE, 5 MG FOR 1 WEEK FOR URGE