BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 2803356 · Received October 17, 2012

    Report

    Report Number
    2135225-2012-00122
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    June 10, 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). COAPTITE LOTS INJECTED DURING SECOND INJECTION: LOT #1017451, EXP DATE 02/2013, MFG DATE 02/2010, LOT #1018599, EXP 04/2013, MFG DATE 04/2010. THE LOT USED FOR THE INJECTION ON 09/27/2010 IS THE SAME LOT AS LISTED. AT THE TIME OF THIS REPORT THE PATIENT'S URINARY TRACT INFECTIONS HAD RESOLVED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOTS #1017308, 1017451 AND 1018599 MET ALL SPECIFICATIONS PRIOR TO RELEASE. NO DEVIATIONS WERE NOTED.

    Description of Event or Problem · 1

    A PATIENT (B)(6) WAS ENROLLED IN THE (B)(6) STUDY FOR STRESS URINARY INCONTINENCE. THE PATIENT WAS INJECTED WITH 3.0 ML OF COAPTITE ON (B)(6) 2010. THE PATIENT RECEIVED A SECOND INJECTION OCCURRING THROUGH THE 6 MONTH VISIT ON (B)(6) 2010. AN ADDITIONAL (THIRD) INJECTION WAS PERFORMED ON (B)(6) 2010. THE PATIENT REPORTED A URINARY TRACT INFECTION ON (B)(6) 2011 WHICH WAS CONFIRMED BY URINALYSIS. THE PATIENT WAS TREATED WITH ANTIBIOTIC, CIPRO 500 MG BID X 7 DAYS ON (B)(6) 2011. THE INFECTION RESOLVED ON (B)(6) 2011. THE PHYSICIAN ASSESSED THE EVENT AS MILD IN SEVERITY AND PROBABLY NOT DEVICE RELATED. THE PATIENT REPORTED A SECOND URINARY TRACT INFECTION ON (B)(6) 2011. THE PATIENT WAS TREATED WITH BACTRIM DS BID X 5 DAYS. THE INFECTION RESOLVED ON (B)(6) 2011. THE PHYSICIAN ASSESSED THE EVENT AS MODERATE IN SEVERITY AND PROBABLY NOT DEVICE RELATED. A THIRD UTI WAS REPORTED BY THE PATIENT ON (B)(6) 2011 AND TREATED WITH BACTRIM DS BID X 7 DAYS. THE PHYSICIAN ASSESSED THE EVENT AS MILD IN SEVERITY AND 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. 1017308

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention