BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 4223985 · Received October 29, 2014

    Report

    Report Number
    2135225-2014-00085
    Event Type
    Other
    Date Received
    October 29, 2014
    Date of Event
    June 23, 2014
    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

    ADD'L CAT # 8005P10, 8005P10, LOT #1029563, 1032138. EXP. DATE: 12/2014, 04/2015, MFR DATE: 04/2012, IMPLANT DATE: (B)(6) 2012. THE PHYSICIAN ASSESSED THE EVENT AS MODERATE IN SEVERITY AND DEFINITELY NOT DEVICE RELATED. AT THE TIME THIS REPORT WAS RECEIVED, THE PT'S URINARY TRACT INFECTIONS HAD RESOLVED. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOTS WERE REVIEWED. ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE WITH 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) 2014 THE PATIENT REPORTED A URINARY TRACT INFECTION. ON (B)(6) 2015 THE PATIENT WAS PRESCRIBED CIPRO 500MG PO BID X 5 DAYS. AS OF 06/24/2014 THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE CASE AS MODERATE AND DEFINITELY NOT DEVICE RELATED. ON (B)(6) 2014 THE PATIENT REPORTED A URINARY TRACT INFECTION. ON (B)(6) 2014 THE PATIENT WAS PRESCRIBED CIPRO 500MG PO BID X 5 DAYS. THE PHYSICIAN ASSESSED THE CASE AS MILD AND DEFINITELY NOT DEVICE RELATED. ON (B)(6) 2015 THE PATIENT REPORTED A URINARY TRACT INFECTION. ON (B)(6) 2015 THE PATIENT WAS PRESCRIBED CIPRO 500MG PO BID X 5 DAYS. AS OF 05/04/2015 THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE CASE AS MILD AND DEFINITELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    A PT, (B)(6) WAS ENROLLED IN (B)(6) STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED WITH 1.7 ML OF COAPTITE FROM LOTS # 1028864 AND 1029563 ON (B)(6) 2012. THE PT WAS INJECTED WITH 2.7ML OF COAPTITE FROM LOTS 1032138 AND 1028864 ON (B)(6) 2012. ON (B)(6) 2012, THE PT REPORTED URGE INCONTINENCE THAT WAS TREATED WITH ENABLEX ON (B)(6) 2012. THE PHYSICIAN ASSESSED THE EVENT AS MODERATE IN SEVERITY AND DEFINITELY NOT DEVICE RELATED. ON (B)(6) 2013, THE PT REPORTED A URINARY TRACT INFECTION AND A URINALYSIS WAS PERFORMED. ON (B)(6) 2013, THE PT WAS PRESCRIBED BACTRIM DS PO QD. THE INFECTION WAS RESOLVED BY (B)(6) 2013. THE PHYSICIAN ASSESSED THE EVENT AS MODERATE IN SEVERITY AND DEFINITELY NOT DEVICE RELATED. ON (B)(6) 2013, THE PT REPORTED A URINARY TRACT INFECTION AND A URINALYSIS WAS PERFORMED. ON (B)(6) 2013, THE PT WAS PRESCRIBED BACTRIM DS PO BID. THE INFECTION WAS RESOLVED BY (B)(6) 2013. THE PHYSICIAN ASSESSED THE EVENT AS MODERATE IN SEVERITY AND DEFINITELY NOT DEVICE RELATED. ON (B)(6) 2013 THE PT REPORTED A URINARY TRACT INFECTION AND A URINALYSIS WAS PERFORMED. ON 05/07/2013 THE PT WAS PRESCRIBED BACTRIM DS PO QD. THE INFECTION WAS RESOLVED BY (B)(6) 2013. THE PHYSICIAN ASSESSED THE EVENT AS MODERATE IN SEVERITY AND DEFINITELY NOT DEVICE RELATED. ON (B)(6) 2013, A URINALYSIS WAS PERFORMED AND A URINARY TRACT INFECTION WAS DIAGNOSED. ON (B)(6) 2013, THE PT WAS PRESCRIBED BACTRIM DS PO BID. THE INFECTION WAS RESOLVED BY (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692161 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC. 1028864

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention