BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1890900 · Received October 29, 2010

    Report

    Report Number
    2135225-2010-00073
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    January 28, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MERZ AESTHETICS, INC (FORMERLY BIOFORM MEDICAL, 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

    (B)(4). THIS EVENT WAS REPORTED IN THE LINE LISTING OF THE (B)(4) STUDY STATUS REPORT FOR (B)(4), SUBMITTED TO THE FDA ON 9/30/2010. SINCE THE ADVERSE EVENT REQUIRED CATHETERIZATION TO CORRECT URINARY RETENTION, THIS EVENT WAS DETERMINED TO BE A REPORTABLE EVENT. THE DEVICE HISTORY RECORDS FOR COAPTITE LOT 1014034 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED. THE SECOND LOT USED ON (B)(6) 2009, AND BOTH SYRINGE LOTS USED FOR THE (B)(6) 2010 INJECTION HAD NOT BEEN RECORDED IN THE PATIENT'S CHART. THE MOST PROBABLE LOT USED WAS REQUESTED BY COAPTITE DISTRIBUTOR, (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. A PATIENT (B)(4), WAS ENROLLED IN THE (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. THE PATIENT WAS INJECTED TWICE; ON (B)(6) 2009, WITH 3.0ML COAPTITE AND AGAIN ON (B)(6) 2010, WITH 2.0ML OF COAPTITE. THE PATIENT DEVELOPED SEVERE URINARY RETENTION AFTER THE SECOND INJECTION ((B)(6) 2010), WHICH WAS TREATED WITH A FOLEY CATHETER. THE CATHETER WAS REMOVED ON (B)(6) 2010 (5 DAYS POST); SYMPTOMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC (FORMERLY BIOFORM MEDICAL, INC) 1014034

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention