BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1890908 · Received October 29, 2010

    Report

    Report Number
    2135225-2010-00059
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    November 23, 2009
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT WAS REPORTED IN THE LINE LISTING OF THE (B)(4) STATUS REPORT FOR (B)(4), SUBMITTED TO THE FDA ON 09/30/2010. SINCE THE ADVERSE EVENT REQUIRED TREATMENT WITH ANTIBIOTICS, THIS EVENT WAS DETERMINED TO BE A REPORTABLE EVENT. THE COAPTITE LOT HAD NOT BEEN RECORDED IN THE PT'S CHART. THE MOST PROBABLE LOT USED WAS REQUESTED BY THE USA DISTRIBUTOR, (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. A PATIENT (B)(6), WAS ENROLLED IN THE (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED WITH 1.0ML COAPTITE ON (B)(6) 2008. THE PT NOTES INDICATES THAT THE PT DEVELOPED TWO URINARY TRACT INFECTIONS ON (B)(6) 2009 AND (B)(6) 2010. THE FIRST UTI (MORE THAN ONE YEAR POST INJECTION), WAS MILD IN SEVERITY AND HAD BEEN DETECTED THROUGH URINALYSIS AND THE PT REPORT. THE PT WAS TREATED WITH ANTIBIOTICS FOR 7 DAYS AND THE SYMPTOMS RESOLVED. THE SECOND UTI (MORE THAN 14 MONTHS POST INJECTION), WAS ALSO MILD IN SEVERITY AND DETECTED IN THE PT REPORT. THE PT WAS TREATED BY HER PRIMARY CARE PHYSICIAN WITH ANTIBIOTICS FOR 10 DAYS AND THE SYMPTOMS RESOLVED. DR. (B)(6) DOES NOT FEEL THAT EITHER OF THESE AES WERE RELATED TO THE COAPTITE IMPLANT.

    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) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention