BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 2466738 · Received January 30, 2012

    Report

    Report Number
    2135225-2012-00021
    Event Type
    Other
    Date Received
    January 30, 2012
    Date of Event
    October 1, 2011
    Report Date
    January 23, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE IMPLANTED FOR 2ND PROCEDURE: (B)(6) 2012. DEVICE MFG DATE FOR 2ND PROCEDURE: UNKNOWN. THE AMOUNT INJECTED DURING EACH TREATMENT WAS NOT SPECIFIED. THE DEVICE HISTORY RECORDS FOR COAPTITE LOT COULD NOT BE REVIEWED, SINCE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT AT THIS TIME. THE PATIENT HAS AN APPOINTMENT WITH THE INJECTING PHYSICIAN ON (B)(6) 2012. ALTHOUGH THIS PATIENT DID NOT CONFIRM AN INFECTION, SHE HAD BEEN PRESCRIBED PAIN MEDS, ANTIBIOTIC AND YEAST MEDICATION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THIS EVENT TO BOSTON SCIENTIFIC CORPORATION, INC ON (B)(4) 2012. THE PATIENT WAS INJECTED WITH COAPTITE INJECTABLE IMPLANT FOR STRESS URINARY INCONTINENCE ON (B)(6) 2011. THAT SAME EVENING, PT SNEEZED EXPERIENCED INCONTINENCE. THE NEXT DAY (B)(6) SHE EXPERIENCED INCONTINENCE ON THE WAY TO THE BATHROOM, TAKING HEAVY STEPS, SNEEZING, COUGHING, LAUGHING WHILE WALKING, ETC. FOR FOUR WEEKS POST INJECTION, THE PATIENT EXPERIENCED PAIN AND WAS UNCOMFORTABLE SITTING FOR ANY LENGTH OF TIME. HER DOCTOR DETECTED A YEAST INFECTION; PRESCRIBED FLUCONAZOLE. SHE ALSO HAD A LOW GRADE FEVER AND ELEVATED BLOOD PRESSURE READINGS FROM MY NORMAL. THE PATIENT WAS ALSO TREATED WITH ANTIBIOTICS AND PAIN MEDS (NOT SPECIFIED). THE PATIENT WAS TREATED WITH COAPTITE FOR A SECOND TIME ON (B)(6) 2012; NO SIGNIFICANT PAIN OR DISCOMFORT, BUT FEELS THE INCONTINENCE HAS NOT IMPROVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other