BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 3429667 · Received October 17, 2013

    Report

    Report Number
    2135225-2013-00128
    Event Type
    Other
    Date Received
    October 17, 2013
    Date of Event
    June 13, 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 THE URINARY RETENTION HAD RESOLVED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT #1032138 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 #1032138 (X2) ON (B)(6) 2012. THE PT 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 MILD AND DEFINITELY DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532238 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC 1032138

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention