BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1890904 · Received October 29, 2010

    Report

    Report Number
    2135225-2010-00077
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    January 15, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MERZ AESTHETICS, INC (FORMALLY BIOFORM MEDICAL, 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

    (B)(4). THIS EVENT WAS REPORTED IN THE LINE LISTING OF THE INTERIM POST-APPROVAL STUDY STATUS FOR PMA P040047, SUBMITTED TO THE FDA ON (B)(4) 2010. SINCE THE ADVERSE EVENT REQUIRED ANTIBIOTICS, TO CORRECT THE UTI, THIS EVENT WAS DETERMINED TO BE A REPORTABLE EVENT. THE DEVICE HISTORY RECORDS FOR COAPTITE LOT 1013660 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    (B)(4). A PATIENT (B)(4) WAS ENROLLED IN THE POST-APPROVAL (B)(4) FOR STRESS URINARY INCONTINENCE. THE PATIENT WAS INJECTED WITH 1.0 ML OF COAPTITE ON (B)(6) 2009. THE PATIENT DEVELOPED A MILD URINARY TRACT INFECTION ON (B)(6) 2010 (2 1/2 MONTHS POST INJECTION), WHICH WAS DETECTED VIA URINALYSIS ON (B)(6) 2010, AND AGAIN VIA CYSTOSCOPY ON (B)(6) 2010. THE PHYSICIAN FEELS THIS IS DEFINITELY NOT RELATED TO THE COAPTITE IMPLANT. THE PATIENT WAS TREATED WITH CIPRO 250 MG ORALLY BID FOR SEVEN DAYS, AT WHICH TIME THE SYMPTOMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC (FORMALLY BIOFORM MEDICAL, INC) 1013660

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention