BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2803310 · Received October 17, 2012

    Report

    Report Number
    2135225-2012-00110
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    April 2, 2012
    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). THE DEVICE HISTORY RECORDS FOR LOTS 1029563 AND 1017929 WERE REVIEWED, ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, NO ABNORMALITIES NOTED. EXPIRATION DATE: 03/2013. DEVICE MANUFACTURE DATE: 03/2010.

    Description of Event or Problem · 1

    A PATIENT (B)(6) WAS ENROLLED IN THE POST-APPROVAL COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PATIENT WAS INJECTED WITH 1.5 ML COAPTITE ON (B)(6) 2012. THE PATIENT EXPERIENCED URINARY URGENCY AND URINARY FREQUENCY ON (B)(6) 2012 AND IS NOT RESOLVED. THE PATIENT IS TREATED WITH VESICARE 5MG PO QD. PER THE PHYSICIAN, THE EVENTS ARE MILD IN SEVERITY AND PROBABLY NOT RELATED TO COAPTITE. IN ADDITION, ON (B)(6) 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND RESOLVED ON (B)(6) 2012. THE PATIENT WAS TREATED WITH BACTRIM DS 800MG 1PO BID. PER THE PHYSICIAN, THE EVENT MILD IN SEVERITY AND DEFINITELY NOT RELATED TO COAPTITE. ON (B)(6) 2012, THE PATIENT EXPERIENCED AN ALLERGIC REACTION AND RESOLVED ON (B)(6) 2012. THE PATIENT WAS TREATED WITH BACTRIM FOR URINARY TRACT INFECTION AND DEVELOPED A RASH ON CHEST, ARMS, SWITCHED TO CIPRO 500MG PO BID. PER THE PHYSICIAN, THE EVENT WAS MILD IN SEVERITY AND DEFINITELY NOT RELATED TO COAPTITE. ON (B)(6) 2012, THE PATIENT EXPERIENCE PRODUCT LEAKAGE AND RESOLVED ON (B)(6) 2012. PER THE PHYSICIAN: GOOD COAPTITE PILLOW ANTERIORLY. DEFICIENCY OF PRODUCT POSTERIORLY, SUGGESTED EXTRUSION OF THE IMPLANT. PER THE PHYSICIAN, THE EVENT WAS MILD IN SEVERITY AND POSSIBLY RELATED TO COAPTITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1029563

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention