BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 3429665 · Received October 17, 2013

    Report

    Report Number
    2135225-2013-00142
    Event Type
    Other
    Date Received
    October 17, 2013
    Date of Event
    July 31, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L COAPTITE LOTS USED FOR INJECTION: 1027727, (EXP DATE 09/2014, MANUFACTURE DATE 09/2011); 1024980 (EXP 04/2014, MANUFACTURE DATE 04/2011); 1028864 (EXP 10/2014, MANUFACTURE DATE 10/2011); 1032764 (EXP 05/2015, MANUFACTURE DATE 05/2012). ADD'L INFO - IMPLANT DATE: (B)(6) 2011; IMPLANT DATE: (B)(6) 2012, IMPLANT DATE: (B)(6) 2012; IMPLANT DATE: (B)(6) 2012. THE DEVICE HISTORY RECORDS FOR ALL 5 LOTS WERE REVIEWED. ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE WITH NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PT ((B)(6)) WAS ENROLLED IN THE COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED WITH 1.0 ML OF COAPTITE LOT #1026118 ON (B)(6) 2011. THE PT WAS INJECTED WITH 1.0 ML OF COAPTITE LOT #1027727 ON (B)(6) 2011. THE PT RECEIVED A THIRD INJECTION OF 1.0 ML OF COAPTITE LOT #1024980 ON (B)(6) 2012. THE PT WAS INJECTED WITH OF 1.0 ML OF COAPTITE LOT #1028864 ON (B)(6) 2012 AND ON (B)(6) 2012 THE PT WAS INJECTED WITH 1.0 ML OF COAPTITE LOT #1032764. THE PT REPORTED URGE INCONTINENCE ON (B)(6) 2012 THROUGH PRESENT. THE PT WAS TREATED ON (B)(6) 2012 WITH ANTICHOLINERGIC MEDICATION TRIAL, SANCTURA XR, 60MG DAILY FOR TWO WEEKS AND TOVIAZ, 8MG DAILY FOR TWO WEEKS. NEITHER DRUG WORKED WELL AND THE PT DISCONTINUED TAKING BOTH OF THEM DUE TO INTOLERANCE TO THE SIDE EFFECTS. THE PHYSICIAN ASSESSED THE EVENT AS MILD IN SEVERITY AND NON-DEVICE RELATED. ON (B)(6) 2012, THE PT REPORTED A URINARY TRACT INFECTION DIAGNOSED BY URINALYSIS. THE PT RECEIVED TREATMENT WITH ANTIBIOTICS; MACROBID AND GENTAMICIN INJECTION ON (B)(6) 2012. THE UTI RESOLVED ON (B)(6) 2012. THE PHYSICIAN ASSESSED THE EVENT AS MILD IN SEVERITY AND DEFINITELY NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532055 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC 1026118

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention