BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 2803336 · Received October 17, 2012

    Report

    Report Number
    2135225-2012-00143
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    August 9, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AT THE TIME OF THIS REPORT THE PT'S URINARY RETENTION RESOLVED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOTS # 1015081 AND 1022345 MET ALL SPECS PRIOR TO RELEASE. ADD'L LOT # 1022345, ADD'L EXP DATE - 11/2013. IMPLANTED DATE - (B)(6) 2011. ADD'L MANUFACTURE DATE: 11/2013.

    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 2.5 ML ON (B)(6) 2010 AND 1.9 ML ON (B)(6) 2011. ON (B)(6) 2011, THE PT REPORTED URINARY RETENTION. EXAMINATION ON (B)(6) 2011, DIAGNOSED THE PT WITH CYSTOCELE AND RECTOCELE. THE PT WAS TREATED WITH STRAIGHT CATHETERIZATION FOR URINARY RETENTION. THE PHYSICIAN ASSESSED THE URINARY RETENTION AS MODERATE IN SEVERITY AND DEFINITELY DEVICE RELATED. THE PHYSICIAN ASSESSED THE CYSTOCELE AND RECTOCELE AS MILD IN SEVERITY AND DEFINITELY NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC 1015081

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention