BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCAVIS 50

    MDR report key: 6966376 · Received October 20, 2017

    Report

    Report Number
    3001239013-2017-00001
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    January 23, 2017
    Report Date
    March 31, 2017
    Manufacturer
    ANGELINI PHARMA INC.
    Product Code
    FKO
    UDI-DI
    00898021000051
    PMA / PMN Number
    K885037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ANGELINI PHARMA INC. WAS RECEIVED A COMPLAINT FILLED WITH (B)(4) ABOUT AN ADVERSE EVENT INVOLVING ALCAVIS 50. ON MARCH 1ST, (B)(4) WAS CONTACTED BY THE PATIENT ABOUT AN INCIDENT THAT HAPPENED ON (B)(6) 2017. THE PATIENT STATED THAT WHILE USING ALCAVIS 50 TO CLEAN THE CATHETER WHILE PREPARING FOR HIS PERITONEAL DIALYSIS, HE SPILLED ALCAVIS 50 ON HIS UNDERPANTS. HE DID NOT NOTICE THAT HIS UNDERWEAR WAS WET AND WENT TO BED WITH THE WET GARMENTS. IN THE NEXT MORNING, HE FELT THAT THE GENITAL AREA WAS UNCOMFORTABLE AND NOTICED HIS UNDERPANTS WAS DISCOLORED. HE THEN REALIZED THAT HE HAD SPILLED ALCAVIS 50 ON HIMSELF AND WENT TO BED WITHOUT EXCHANGE IT. HE NOTICED THAT THE GENITALS WERE REDDISH AND SENSITIVE; HE THEN SHOWERED AND WASHED THE AFFECTED AREA WITH ANTIMICROBIAL SOAP, TREATED WITH HYDROGEN PEROXIDE, AND WITH TRIPLE ANTIBIOTIC OINTMENT. TWO/THREE DAYS LATER, HE HAD A VISIT WITH HIS NEPHROLOGIST WHO REFERRED HIM TO THE PRIMARY DOCTOR, AND THIS TO HIS UROLOGIST. WITH THE UROLOGIST, HE BEGAN TREATMENT WITH LIDOCAINE GEL (4%) AND CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM. REGION IS STILL HAVING AN OPEN WOULD AND IS STILL PAINFUL. PATIENT IS DIABETIC AND UNDERGOES HYPERBARIC TREATMENT. PATIENT CONTINUES USING ALCAVIS 50.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745463 ALCAVIS 50 HIGH LEVEL DISINFECTANT FOR CONNECTIONS FKO ANGELINI PHARMA INC. 00898021000051

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other