BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 3429657 · Received October 17, 2013

    Report

    Report Number
    2135225-2013-00115
    Event Type
    Other
    Date Received
    October 17, 2013
    Date of Event
    April 16, 2012
    Report Date
    September 20, 2013
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2012 THE PT HAD URINARY RETENTION THAT WAS DIAGNOSED BY THE DOCTOR AND TREATED BY A FOLEY CATHETERIZATION. THIS RESOLVED ON (B)(6) 2012. PER THE PHYSICIAN, THE EVENT WAS OF MODERATE SEVERITY AND DEFINITELY RELATED TO COAPTITE. ON (B)(6) 2012 THE PT SAW BLOOD IN HER URINE. SHE WENT TO THE ER. THE ER PHYSICIAN DIAGNOSED HER WITH MILD GROSS HEMATURIA. PER PHYSICIAN, HEMATURIA CAUSED BY SUBJECT FREQUENT SELF CATHETERIZATION. THE RESOLVED ON (B)(6) 2012. PER THE PHYSICIAN, THE EVENT WAS OF MILD SEVERITY AND PROBABLY NOT RELATED TO COAPTITE. ON (B)(6) 2012 THE PT HAD A URINARY TRACT INFECTION THAT WAS TREATED WITH MACROBID 100 MG ORAL EVERY 2 HRS FOR 3 DAYS. ON (B)(6) 2013 A UA WAS PERFORMED AND BACTERIA WAS FOUND TO BE RARE. PER THE PHYSICIAN, THE EVENT WAS OF MILD SEVERITY AND DEFINITELY NOT RELATED TO COAPTITE. ON (B)(6) 2012 THE PT HAD URGE INCONTINENCE THAT WAS TREATED WITH DITROPAN/LEVSIN. THIS RESOLVED ON (B)(6) 2012. ON (B)(6) 2012 THE PT HAD A TIA THAT WAS DIAGNOSED BY THE ER PHYSICIAN AND TREATED WITH 81 MG ASPIRIN, 1 X DAY. THERE WAS A NEGATIVE SCAN OF THE HEAD. NO MASS EFFECTS IDENTIFIED. NO EVIDENCE OF INTERCRANIAL HEMORRHAGE. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT WAS REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE. THERE WERE NO ABNORMALITIES. LOT: 1030939, EXP DATE: 03/2015. DATE OF INJECTION: (B)(6) 2012. MANUFACTURER DATE FOR LOT 1030939 IS 03/2012.

    Description of Event or Problem · 1

    A PT ((B)(6)) WAS ENROLLED IN THE POST-APPROVAL STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2010 THE PT WAS INJECTED WITH 2.0 ML OF COAPTITE, LOT 1015082. ON (B)(6) 2010 THE PT WAS INJECTED WITH 2.5 ML OF COAPTITE LOTS 1017312, 1015082. ON (B)(6) 2012 THE PT WAS INJECTED WITH 2.0 ML OF COAPTITE LOT 1030939.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532937 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC. 1015082, 1017312

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention