BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 2803305 · Received October 17, 2012

    Report

    Report Number
    2135225-2012-00134
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    December 21, 2008
    Report Date
    September 17, 2012
    Manufacturer
    MERZ AESTHETICS, 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). THE PHYSICIAN ASSESSED THE UTI AS MILD AND DEFINITELY NOT RELATED TO THE DEVICE. THE PHYSICIAN ASSESSED THE WEAKNESS AS MILD AND DEFINITELY NOT RELATED TO THE DEVICE. THE PHYSICIAN ASSESSED THE URINARY URGENCY AS MILD AND DEFINITELY NOT RELATED TO THE DEVICE. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER WAS REVIEWED, ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PT (B)(6) WAS ENROLLED IN THE (B)(6) STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2008 THE PT WAS INJECTED WITH 2.0ML OF COAPTITE. ON (B)(6) 2008 THE PT REPORTED THAT SHE HAD A URINARY TRACT INFECTION (UTI). THIS WAS CONFIRMED BY A URINALYSIS. ON (B)(6) 2008 THE PT WAS PRESCRIBED AN ANTIBIOTIC COURSE. THE PT RESOLVED ON (B)(6) 2008. ON (B)(6) 2009, THE PT REPORTED GENERALIZED WEAKNESS. ON (B)(6) 2009, THE PT REPORTED THAT SHE HAD URINARY URGENCY. ON (B)(6) 2009, THE PT WAS PRESCRIBED N ANTICHOLINERGIC MEDICATION. THE URINARY URGENCY CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1009279

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention