BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 3429666 · Received October 17, 2013

    Report

    Report Number
    2135225-2013-00130
    Event Type
    Other
    Date Received
    October 17, 2013
    Date of Event
    August 2, 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

    AT THE TIME OF THIS REPORT BOTH THE URINARY RETENTION AND THE UTI HAD RESOLVED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT #1031984 MET ALL SPECS 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 2.0 ML OF COAPTITE LOT #1031984 ON (B)(6) 2012. THE PT REPORTED URINARY RETENTION FOLLOWING THE PROCEDURE ON 08/02/2012 DIAGNOSED BY POST VOID RESIDUAL. THE PT WAS TREATED WITH FOLEY CATHETERIZATION ON 08/03/2012. THE RETENTION RESOLVED ON 08/04/2012. THE PHYSICIAN ASSESSED THE SEVERITY OF THE EVENT AS MILD AND DEFINITELY DEVICE-RELATED. ON (B)(6) 2012, THE PT REPORTED A URINARY TRACT INFECTION. THE PT WAS TREATED WITH MACROBID 100 MG PO BID #14 ON (B)(6) 2012. THE UTI RESOLVED ON (B)(6) 2012. THE PHYSICIAN ASSESSED THE SEVERITY OF THE EVENT AS MILD AND PROBABLY NOT DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532842 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC. 1031984

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention