BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1890895 · Received October 29, 2010

    Report

    Report Number
    2135225-2010-00068
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    September 9, 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
    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 REPORT 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 COAPTITE LOT HAD NOT BEEN RECORDED IN THE PT'S CHART. THE MOST PROBABLE LOT USED WAS REQUESTED BY THE USA DISTRIBUTOR, BOSTON SCIENTIFIC CORPORATION.

    Description of Event or Problem · 1

    (B)(4). A PT (B)(6), WAS ENROLLED IN THE (B)(4) FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED WITH 2.0 ML COAPTITE ON (B)(6) 2008. THE PT DEVELOPED A MILD URINARY TRACT INFECTION ON (B)(6) 2009 (MORE THAN 18 MONTHS POST INJECTION). THE PHYSICIAN FEELS THIS IS DEFINITELY NOT RELATED TO THE COAPTITE IMPLANT. THE PT WAS TREATED WITH MACRODANTIN FOR 5 DAYS, AT WHICH TIME THE SYMPTOMS RESOLVED. ALSO REPORTED WAS ON (B)(6) 2010, THAT PT DEVELOPED CYSTOCELE, WHICH WAS NOT TREATED. AGAIN, THE PHYSICIAN DOES NOT FEEL THIS IS 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.) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention