BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 770313 · Received October 13, 2006

    Report

    Report Number
    2135225-2006-00013
    Event Type
    Other
    Date Received
    October 13, 2006
    Date of Event
    June 9, 2006
    Report Date
    October 12, 2006
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING F/U WITH A PHYSICIAN, IT WAS REPORTED THAT THE PT HAD BEEN INJECTED IN 2006. A FOLEY CATHETER WAS INSERTED THE SAME DAY. THE PT REMOVED THE CATHETER 4 DAYS LATER, AS THE SYMPTOMS HAD RESOLVED. THE DEVICE HISTORY RECORDS INDICATE THAT LOT 1002405 MET SPECIFICATIONS AT THE TIME OF RELEASE. THIS EVENT WAS NOT INITIALLY REPORTED AS A SERIOUS INJURY. UPON REVIEW OF THE REGULATIONS, IT WAS NOTED THAT THIS EVENT SHOULD BE REPORTED. BIOFORM UNDERSTANDS THAT THIS INITIAL REPORT IS BEYOND THE 30-DAY TIME FRAME.

    Description of Event or Problem · 1

    DR. SWARTZ REPORTED THAT A PT WAS INJECTED WITH 5 SYRINGES OF COAPTITE FOR A URETHRAL BULKING PROCEDURE. THE PT HAD GONE INTO URINARY RETENTION APPROX 2 MOS POST INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. * 1002405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention