BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1890856 · Received October 29, 2010

    Report

    Report Number
    2135225-2010-00062
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    August 6, 2009
    Report Date
    October 1, 2010
    Manufacturer
    MERZ AESTHETICS, INC (FORMERLY BIOFORM MEDICAL, 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

    ADDITIONAL INFO: CATALOG: 8005P10, LOT: 1011122, EXP DATE: 10/31/2011, IMP DATE: (B)(6) 2009, MFG DATE: 10/2008. CATALOG: 8005P10, LOT: 1011520, EXP DATE: 11/30/2011, IMP DATE: (B)(6) 2009, MFG DATE: 11/2008. CATALOG: 8005P10, LOT: 1012201, EXP DATE: 01/31/2012, IMP DATE: (B)(6) 2009, MFG DATE: 01/2009. (B)(4). THIS EVENT WAS REPORTED IN THE LINE LISTING OF THE (B)(4) STUDY STATUS REPORT FOR (B)(4), SUBMITTED TO THE FDA ON 09/30/2010. SINCE THE ADVERSE EVENT REQUIRED ANTIBIOTICS, TO CORRECT THE BOTH UTIS, THIS EVENT WAS DETERMINED TO BE A REPORTABLE EVENT. THE DEVICE HISTORY RECORDS FOR COAPTITE LOTS 1010449, 1011122, 1011520 AND 1012201 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED FOR ANY OF THESE LOTS.

    Description of Event or Problem · 1

    (B)(4) STUDY. A PATIENT (B)(6), WAS ENROLLED IN THE (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED ON THREE OCCASIONS; 2.0ML OF COAPTITE ON (B)(6) 2009, ANOTHER 2.0ML COAPTITE ON (B)(6) 2009 AND A FINAL 2.0ML COAPTITE ON (B)(6) 2009. THERE WERE NO REPORTED SYMPTOMS FOLLOWING THE (B)(6) COAPTITE INJECTIONS. AFTER THE FINAL COAPTITE TREATMENT ((B)(6) 2009), THE PT DEVELOPED URETHRAL SWELLING AND DIFFICULTY VOIDING. THE BLADDER ULTRASOUND DID NOT SHOW URINARY RETENTION. A FOLEY CATHETER WAS PLACED, AND IT WAS NOTED THAT THE PT HAD A URINARY TRACT INFECTION WITH PURULENT, CLOUDY URINE. THE CATHETER ALLOWED THE INFECTED URINE TO BE DRAINED EFFECTIVELY. THE PT WAS ALSO TREATED WITH 10-DAY DOSAGE OF ANTIBIOTICS FOR THE UTI. THE PT DEVELOPED A SECOND UTI ON (B)(6) 2009 AND WAS AGAIN TREATED WITH ANTIBIOTICS; SYMPTOMS RESOLVED ON (B)(6) 2009. THE PT REPORTED A YEAST INFECTION ON (B)(6) 2009, AND TREATED WITH DIFLUCAN (TABLET); THE YEAST INFECTION RESOLVED BY (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC (FORMERLY BIOFORM MEDICAL, INC) 1010449

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention