BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 2334557 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00137
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    December 17, 2011
    Report Date
    September 29, 2015
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT WAS REPORTED IN THE INTERIM POST-APPROVAL STUDY STATUS REPORT FOR PMA P040047, (B)(4) 2011. THE PHYSICIAN DETERMINED THE UTI TO BE MILD AND THAT IT WAS DEFINITELY NOT RELATED TO THE COAPTITE. AT THE TIME OF THIS REPORT, THE SYMPTOMS HAD RESOLVED. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2011 THE PATIENT REPORTED A URINARY TRACT INFECTION (DIAGNOSED BY EMR). IT WAS REPORTED THAT ON (B)(6) 2014 THE PATIENT WAS TREATED WITH BACTRIM 1 TAB 2XDAY FOR 3 DAYS. (NOTE: THE REPORTER MAY HAVE REPORTED THE YEAR INCORRECTLY.) AS OF 12/20/2011 THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE EVENT AS MILD AND PROBABLY NOT DEVICE RELATED. ON (B)(6) 2012 THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION THAT WAS DIAGNOSED BY A URINALYSIS. ON (B)(6) 2012 THE PATIENT WAS PRESCRIBED CIPRO 500MG 2 X DAY. THE PHYSICIAN ASSESSED THE EVENT AS MILD AND PROBABLY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    A PT (B)(6) WAS ENROLLED IN THE (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. THE PT HAS NOT HAD ANY PREVIOUS COAPTITE TREATMENTS. ON (B)(6) 2009, THE PT WAS INJECTED WITH 2.0 ML OF COAPTITE. ON (B)(6) 2011, THE PT HAD A URINARY TRACT INFECTION THAT WAS RESOLVED ON (B)(6) 2010. THE PT WAS ALREADY ON PROPHYLAXIS CIPRO FOR URINARY TRACT INFECTIONS. THE PT'S PRIMARY CARE PROVIDER WANTED THE PT TO CONTINUE. A URINE CULTURE WAS OBTAINED AND NO RESULTS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1010148

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention