BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2334469 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00141
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    January 28, 2010
    Report Date
    October 7, 2011
    Manufacturer
    MERZ AESTHETICS, INC
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT WAS REPORTED IN THE (B)(4) STUDY STATUS REPORT FOR PMA P040047, 09/16/2011. ADD'L LOT NUMBER OF COAPTITE INJECTED INTO THE PT: 1014618 EXP DATE: 08/2012 MFR DATE: 08/2009 DATE INJECTED: (B)(6) 2010. AT THE TIME THIS REPORT WAS RECEIVED, THE PT'S CONDITIONS WERE RESOLVED. THE PHYSICIAN DETERMINED THAT THE URINARY RETENTION WAS MODERATE AND WAS DEFINITELY RELATED TO THE COAPTITE. THE PHYSICIAN DETERMINED THAT THE ABCESS, (B)(6) WAS SEVERE AND WAS DEFINITELY NOT RELATED TO THE COAPTITE. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBERS WAS REVIEWED, ALL REQUIRED TESTING SPECS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PT (B)(6) WAS ENROLLED IN THE (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. THE PT HAS NOT HAD ANY PREVIOUS COAPTITE TREATMENTS. THE PT HAS HAD 4 PRIOR SURGERIES FOR INCONTINENCE. ON (B)(6) 2009, THE PT WAS INJECTED WITH 2.0 ML OF COAPTITE (LOT 1013205). ON (B)(6) 2010, THE PT WAS INJECTED WITH 2.0 ML OF COAPTITE (LOT 1014618). ON (B)(6) 2010, THE PT WAS DIAGNOSED WITH URINARY RETENTION THAT WAS TREATED BY CATHETERIZATION (FOLEY). THE URINARY RETENTION RESOLVED ON (B)(6) 2010. ON (B)(6) 2011, THE PT WAS DIAGNOSED WITH AN ABCESS, (B)(6). DRAINAGE WAS ATTEMPTED AND AN ANTIBIOTIC WAS PRESCRIBED (NAME, DOSE AND DURATION NOT PROVIDED). THE ABCESS WAS RESOLVED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC 1013205

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention