BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 2804314 · Received October 17, 2012

    Report

    Report Number
    2135225-2012-00139
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    March 3, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFO: LOT #: 1012957; EXP DATE: 03/2012; MFR DATE: 03/2009. (B)(4). THE PT REPORTED A CANDIDAL VAGINITIS INFECTION ON (B)(6) 2011 DIAGNOSED BY PHYSICIAN EXAM. TREATMENT WITH DIFLUCAN 150 MG; ONE TABLET NOW, ONE IN 3 DAYS AND ONE ON THE 6TH DAY. THE INFECTION RESOLVED ON (B)(6) 2011 AND WAS ASSESSED AS MILD IN SEVERITY AND DEFINITELY NOT DEVICE RELATED. THE PT ALSO REPORTED A URINARY TRACT INFECTION ON (B)(6) 2011 WHICH WAS CONFIRMED BY URINALYSIS. TREATMENT PERFORMED ON (B)(6) 2011 OF A URINE CULTURE, AND SENSITIVITY, CLINDAMYCIN WAS DISCONTINUED AND CIPROFLAXACIN 500 MG 1 PO BED FOR 10 DAYS WAS STARTED. THE INFECTION WAS REPORTED AS RESOLVED ON (B)(6) 2011. THE PHYSICIAN ASSESSED THE EVENT AS MILD IN SEVERITY AND DEFINITELY NOT DEVICE RELATED. AT THE TIME OF THIS REPORT ALL OF THE PT'S ADVERSE EVENTS INCLUDING THE URINARY TRACT INFECTION HAD RESOLVED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOTS #1010448 AND 1012957 MET ALL SPECS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    A PT (B)(6) WAS ENROLLED IN (B)(6) STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED WITH 2 ML ON (B)(6) 2009. THE PT REPORTED HEART PALPITATIONS ON (B)(6) 2010. THE PHYSICIAN PERFORMED A HOLTER EXAM (NEGATIVE RESULTS), CONSULT WITH A CARDIOLOGIST AND AN ECHOCARDIOGRAM. THE PHYSICIAN ASSESSED THE EVENT AS MILD IN SEVERITY AND DEFINITELY NOT DEVICE RELATED. ON (B)(6) 2011, THE PT REPORTED AN ABSCESS TO THE LEFT PERINEUM DIAGNOSED BY PHYSICIAN EXAM. THE ABSCESS WAS TREATED ON (B)(6) 2011 BY INCISION AND DRAINAGE OF ABSCESS; WOUND PACKED WITH GAUZE. ANTIBIOTIC CLINDAMYCIN 300 MG EVERY 6 HOURS FOR 10 DAYS; LORTAB 5/500 MG EVERY 6 HOURS FOR PAIN; BACTROBAN OINTMENT ADDED ON (B)(6) 2011 FOR USAGE TID FOR 10 DAYS. THE ABSCESS RESOLVED ON (B)(6) 2011 AND ASSESSED AS MODERATE 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 1010448, 1012957

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention