BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 2803312 · Received October 17, 2012

    Report

    Report Number
    2135225-2012-00120
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    May 23, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT # 1024083, EXPIRATION DATE: 02/2014. DEVICE MANUFACTURE DATE: 02/01/2011. AT THE TIME OF THIS REPORT, BOTH THE URINARY RETENTION AND THE URINARY TRACT INFECTION HAD RESOLVED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOTS #1020710 AND #1024083 MET ALL SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    A PATIENT (B)(6) WAS ENROLLED IN THE COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PATIENT WAS INJECTED WITH 2.0 ML OF COAPTITE ON (B)(6) 2011. THE PATIENT REPORTED URINARY RETENTION ON (B)(6) 2011, WHICH WAS CONFIRMED USING PVR ULTRASOUND. THE PATIENT WAS TREATED WITH FOLEY CATHETERIZATION ON (B)(6) 2011. THE RETENTION RESOLVED ON (B)(6) 2011. THE PHYSICIAN ASSESSED THE EVENT AS MODERATE IN SEVERITY AND DEVICE RELATED. THE PATIENT REPORTED A URINARY TRACT INFECTION ON (B)(6) 2011, WHICH WAS CONFIRMED WITH URINALYSIS TESTING. THE PATIENT WAS TREATED ON (B)(6) 2011 WITH CIPRO, 500 MG BID X 7 DAYS. THE URINARY TRACT INFECTION RESOLVED ON (B)(6) 2011. THE PHYSICIAN ASSESSED THE EVENT AS MODERATE BUT PROBABLY NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1020710

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention GELNIQUE 10% (10 DAYS)