BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 2804319 · Received October 17, 2012

    Report

    Report Number
    2135225-2012-00117
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    July 20, 2011
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR LOTS 1013660 (EXP DATE 6/2012, MFG 6/2009), 1015082 (EXP DATE 9/2012, MFG 9/2009) AND 1015604 (EXP DATE 10/2012, MFG 10/2009) WERE REVIEWED, ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PT (B)(6), WAS ENROLLED IN (B)(6) STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2009, THE PT WAS INJECTED WITH 1 ML COAPTITE, LOT 1013660. ON (B)(6) 2009, THE PT WAS INJECTED WITH 1 ML COAPTITE, LOT 1015082. ON (B)(6) 2010, THE PT WAS INJECTED WITH 1 ML COAPTITE, LOT 1015604. ON (B)(6) 2009, THE PT DEVELOPED CLOT RETENTION OF URINE DIAGNOSED BY PT REPORT. THE PT WAS TREATED WITH BLADDER IRRIGATION AND RECOVERED ON THE SAME DAY. PER PHYSICIAN, THE EVENT WAS OF MODERATE SEVERITY AND PROBABLY NOT RELATED TO COAPTITE. ON (B)(6) 2010, THE PT DEVELOPED URETHRAL PROLAPSE DIAGNOSED BY PERIURETHRAL EXAM. THE PT WAS NOT TREATED AND RECOVERED BY (B)(6) 2010. PER PHYSICIAN, THE EVENT WAS OF MILD SEVERITY AND DEFINITELY NOT RELATED TO COAPTITE. ON (B)(6) 2010, THE PT DEVELOPED CARUNCLE DIAGNOSED BY PERIURETHRAL EXAM. THE PT WAS NOT TREATED AND RECOVERED BY (B)(6) 2010. PER PHYSICIAN, THE EVENT WAS OF MILD SEVERITY AND PROBABLY NOT RELATED TO COAPTITE. ON (B)(6) 2010, THE PT DEVELOPED HEMORRHAGE DIAGNOSED BY PT REPORT. THE PT RECEIVED TWO UNITS OF BLOOD TRANSFUSION ON (B)(6) 2010 AND RECOVERED BY (B)(6) 2010. PER PHYSICIAN, THE EVENT WAS OF MODERATE SEVERITY AND PROBABLE NOT RELATED TO COAPTITE. ON (B)(6) 2010, THE PT DEVELOPED URGE INCONTINENCE DIAGNOSED BY PT REPORT. THE PT WAS NOT TREATED, NO RECOVERY INFO IS KNOWN. PER PHYSICIAN, THE EVENT WAS OF MILD SEVERITY AND DEFINITELY NOT RELATED TO COAPTITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention