BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2804321 · Received October 17, 2012

    Report

    Report Number
    2135225-2012-00119
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    August 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

    ADDITIONAL DEVICE INFO: LOT #: 1024083; EXP DATE: 02/2014; MFR DATE: 02/2011. (B)(4). AT THE TIME OF THIS REPORT THE RETENTION HAD RESOLVED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOTS #1022220 AND #1024083 MET ALL SPECS PRIOR TO RELEASE. NO ABNORMALITIES WERE NOTED.

    Description of Event or Problem · 1

    A PT (B)(6) WAS ENROLLED IN THE (B)(6) STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED WITH 2 ML OF COAPTITE ON (B)(6) 2011. THE PT REPORTED URINARY RETENTION ON (B)(6) 2011. THE PT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC 1022220, 1024083

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention