BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 3429670 · Received October 17, 2013

    Report

    Report Number
    2135225-2013-00119
    Event Type
    Other
    Date Received
    October 17, 2013
    Date of Event
    October 24, 2013
    Report Date
    September 29, 2015
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD FOR THE REPORTED LOT WAS REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE. THERE WERE NO ABNORMALITIES. LOTS: 1033384, 1032765. EXP DATE: 06/2015, 05/2015. MANUFACTURE DATE FOR LOT: 1033384 IS 06/2012. MANUFACTURE DATE FOR LOT 1032765 IS 05/2012.

    Description of Event or Problem · 1

    A PT ((B)(6)) WAS ENROLLED IN THE POST-APPROVAL STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2012 THE PT WAS INJECTED WITH 3.0 ML OF COAPTITE, LOT 1028551, 1027725. ON (B)(6) 2012 THE PT WAS INJECTED WITH 2.5 ML OF COAPTITE, LOT 1033384, 1032765. ON (B)(6) 2012 THE PT HAD URGE INCONTINENCE THAT WAS TREATED WITH VESICARE ON (B)(6) 2012. THIS WAS RESOLVED BY (B)(6) 2012. PER THE PHYSICIAN THIS WAS MODERATE IN SEVERITY AND DEFINITELY RELATED TO THE COAPTITE. ON (B)(6) 2012 THE PT HAD URINARY RETENTION THAT WAS NOT TREATED AND WAS RESOLVED BY (B)(6) 2012. PER THE PHYSICIAN THIS WAS MODERATE IN SEVERITY AND WAS DEFINITELY RELATED TO THE COAPTITE. ON (B)(6) 2012 THE PT HAD URINARY FREQUENCY. THIS WAS TREATED WITH VESICARE 10 MG ON (B)(6) 2012. THIS WAS RESOLVED BY (B)(6) 2012. PER THE PHYSICIAN THIS WAS MODERATE IN SEVERITY AND POSSIBLY RELATED TO THE COAPTITE. ON (B)(6) 2013 THE PT HAD URINARY FREQUENCY THAT WAS TREATED WITH MYRBETRIQ 25 MG QD ON (B)(6) 2013. THIS WAS RESOLVED BY (B)(6) 2013. PER THE PHYSICIAN THIS WAS OF MODERATE SEVERITY AND POSSIBLY RELATED TO THE COAPTITE. ON (B)(64 )2013 THE PT REPORTED A URINARY TRACT INFECTION (UTI). THE UTI WAS TREATED ON (B)(6) 2013 WITH CIPRO 500 MG X 7 DAYS THEN NITROFURANTOIN 100 MG X 90 DAYS. THE UTI WAS RESOLVED BY (B)(6) 2013. PER THE PHYSICIAN THE UTI WAS MILD IN SEVERITY AND WAS PROBABLY NOT RELATED TO THE COAPTITE.

    Description of Event or Problem · 1

    THE PATIENT WAS ENROLLED IN THE POST-APPROVAL STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2013. THE HAD A URINARY TRACT INFECTION THAT WAS DIAGNOSED BY A URINALYSIS. ON (B)(6) 2013. THE PATIENT WAS PRESCRIBED CIPRO 500MG BID X 7 DAYS. THE PHYSICIAN ASSESSED THE EVENT AS MILD AND PROBABLY NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532342 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC. 1028551, 1027725

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention