BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1890911 · Received October 29, 2010

    Report

    Report Number
    2135225-2010-00063
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    August 19, 2010
    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

    (B)(4). ADDITIONAL INFO: CATALOG: 8005P10, LOT: 1012201, EXPIRATION DATE: 01/31/2012. ADDITIONAL DEVICE MANUFACTURE DATE: 01/2009. CATALOG: 8005P10, LOT: 1012833, EXPIRATION DATE: 03/31/2012. ADDITIONAL DEVICE MANUFACTURE DATE: 03/2009. THIS EVENT WAS REPORTED IN THE LINE LISTING OF THE (B)(4) REPORT FOR (B)(4), SUBMITTED TO THE FDA ON 09/30/2010. SINCE THE ADVERSE EVENT REQUIRED ANTIBIOTICS FOR THE CYSTITIS AND UTI, AND CATHETERIZATION TO CORRECT URINARY RETENTION, THIS EVENT WAS DETERMINED TO BE A REPORTABLE EVENT. THE DEVICE HISTORY RECORDS FOR COAPTITE LOTS 1012011, 1012201 AND 1012833 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED FOR ANY LOT.

    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; 2.0 ML OF COAPTITE ON (B)(6) 2009, ANOTHER 2.0 ML COAPTITE ON (B)(6) 2009 AND A FINAL 2.0 ML COAPTITE ON (B)(6) 2009. THERE WERE NO REPORTED SYMPTOMS FOLLOWING THE (B)(6) COAPTITE INJECTIONS. THE PT DEVELOPED CYSTITIS ON (B)(6) 2010 AND WAS TREATED WITH AN ANTIBIOTIC FOR 10 DAYS. THE PHYSICIAN FEELS THIS WAS DEFINITELY NOT RELATED TO THE COAPTITE IMPLANT. ON (B)(6) 2010, THE PT DEVELOPED URINARY RETENTION, WHICH WAS DETECTED WITH A BLADDER ULTRASOUND, AND TREATED WITH A FOLEY CATHETER. THE CATHETER WAS IN PLACE FOR 5 DAYS, AT WHICH TIME THE SYMPTOMS RESOLVED. WHILE THE CATHETER WAS IN PLACE, THE PT ALSO DEVELOPED A URINARY TRACT INFECTION; TREATED WITH A 10-DAY DOSAGE OF ANTIBIOTICS. ON (B)(6) 2009, THE PT HAD URGE INCONTINENCE, TREATED WITH ANTICHOLINERGIC MEDICATION, THROUGH THE END OF THE STUDY ON (B)(6) 2010.

    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) 1012011

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention