BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 3429622 · Received October 17, 2013

    Report

    Report Number
    2135225-2013-00146
    Event Type
    Other
    Date Received
    October 17, 2013
    Date of Event
    August 23, 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
    FL, 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 #1031985 MET ALL SPECIFICATIONS PRIOR TO RELEASE WITH NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PATIENT ((B)(6)) WAS ENROLLED IN THE COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PATIENT WAS INJECTED WITH 2.0 ML OF COAPTITE LOT #1031985 ON (B)(6) 2012. THE PATIENT REPORTED URINARY RETENTION FOLLOWING THE PROCEDURE ON (B)(6) 2012 AND WAS TREATED WITH FOLEY CATHETERIZATION. THE RETENTION RESOLVED ON (B)(6) 2012. THE PHYSICIAN ASSESSED THE SEVERITY OF THE EVENT AS MODERATE AND POSSIBLY DEVICE-RELATED. ON (B)(6) 2012 THE PATIENT REPORTED A URINARY TRACT INFECTION. THE PATIENT WAS PRESCRIBED BACTRIM, BID #10 ON (B)(6) 2012. THE UTI RESOLVED ON (B)(6) 2012. THE PHYSICIAN ASSESSED THE SEVERITY OF THE EVENT AS MODERATE AND PROBABLY NOT DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532067 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC. 1031985

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention