BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2334569 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00129
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    August 25, 2010
    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

    ADDITIONAL INFO FOR SECTIONS: CATALOG# 8005P10, LOT# 1018439, EXPIRATION DATE: 04/2013. IMPLANT DATE: (B)(6) 2010. MANUFACTURE DATE: 04/2010. CATALOG# 8005P10, LOT# 1020122, EXPIRATION DATE: 07/2013. IMPLANT DATE: (B)(6) 2011. MANUFACTURE DATE: 07/2010. THIS EVENT WAS REPORTED IN THE INTERIM POST-APPROVAL STUDY STATUS REPORT FOR PMA (B)(4), (B)(4) 2011. AT THE TIME OF THIS REPORT, THE SYMPTOMS HAD RESOLVED. THE DEVICE HISTORY RECORDS FOR THREE COAPTITE LOTS 1018438, 1018439 AND 1020122 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PT (B)(6) WAS ENROLLED IN THE (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED TWICE, THE FIRST TIME ON (B)(6) 2010 WITH 3.0ML OF COAPTITE (LOT 1018438 X 2 AND 1018439) AND AGAIN WITH 2.0ML OF COAPTITE (LOT 1020122 X2) ON (B)(6) 2011. THE PT REQUIRED FOLEY CATHETER PLACEMENT PRIOR TO LEAVING THE OFFICE, AFTER THE (B)(6) COAPTITE PROCEDURE. THE CATHETER REMAINED IN PLACE FOR ONE DAY. THE INFO WAS LISTED IN THE 1 MONTH POST AE FORM; THE AE SEVERITY WAS MILD. THE PT ALSO DEVELOPED A URINARY TRACT INFECTION ON (B)(6) 2010, AND WAS TREATED WITH ANTIBIOTICS UNTIL RESOLUTION ON (B)(6) 2010. THE PHYSICIAN ASSESSED THE SEVERITY OF THE UTI AS MILD AND DEFINITELY NOT RELATED TO THE COAPTITE INJECTION. ON (B)(6) 2011, DURING URINALYSIS AND PT'S REPORT, THE PT HAD DEVELOPED A SECOND UTI, AND WAS TREATED WITH ANTIBIOTICS. THE SYMPTOMS RESOLVED ON (B)(6) 2011; PHYSICIAN ASSESSMENT WAS MILD SEVERITY AND DEFINITELY NOT RELATED TO THE (B)(6) COAPTITE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC 1018438

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention