BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 770423 · Received October 13, 2006

    Report

    Report Number
    2135225-2006-00019
    Event Type
    Other
    Date Received
    October 13, 2006
    Date of Event
    July 28, 2006
    Report Date
    October 12, 2006
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP WITH THE PHYSICIAN, IT WAS REPORTED THAT A FOLEY CATHETER WAS INSERTED PRIOR TO THE PATIENT'S RELEASE. THE PATIENT RETURNED FOR A FOLLOW-UP VISIT TWO WEEKS LATER IN WHICH ALL SYMPTOMS HAD RESOLVED. THE DEVICE HISTORY RECORDS INDICATE THAT COAPTITE LOT 1002381 MET SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    DR REPORTED THAT A PATIENT WAS INJECTED WITH ABOUT 2 SYRINGES OF COAPTITE, FOR A URETHRAL BULKING PROCEDURE, IN 2006. IT WAS REPORTED, THAT THE PATIENT IS STILL IN URINARY RETENTION ONE WEEK POST INJECTION AND IS SELF-CATHETERIZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. * 1002381

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention