BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVICIDE

    MDR report key: 6152222 · Received December 7, 2016

    Report

    Report Number
    1722021-2016-00002
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    August 3, 2015
    Report Date
    November 28, 2016
    Manufacturer
    METREX RESEARCH
    Product Code
    LRJ
    PMA / PMN Number
    K951123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINANT ALLEGED THAT HE HAD EXPERIENCED A CHEMICAL BURN AND AN INTENSE BURNING PAIN FROM EXPOSURE TO CAVICIDE. THE COMPLAINANT ALLEGED THAT A DOCTOR AND A NURSE IN THE EMERGENCY ROOM AT UNIVERSITY MEDICAL CENTER (UMC) HAD SPRAYED CAVICIDE DIRECTLY INTO HIS OPEN WOUND MULTIPLE TIMES BEFORE SUTURES WERE APPLIED. THE SEVERE BURNING PAIN INCREASED IN INTENSITY AS MORE CAVICIDE SPRAY WAS APPLIED TO THE OPEN WOUND. IT WAS NOTED THAT THE COMPLAINANT RETURNED TO THE EXAMINATION ROOM AND DEMANDED TO HAVE THE SUTURES REMOVED AND HIS WOUND RINSED. THE HOSPITAL STAFF REMOVED THE SUTURES, RINSED THE WOUND WITH WATER AND RE-SUTURED IT. LIDOCAINE WAS APPLIED TO THE WOUND. DAYS LATER, THE COMPLAINANT WENT TO THE (B)(6) BURN UNIT AND WAS REPORTED THAT HE DID OBTAIN SATISFACTORY TREATMENT THERE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT WAS PROVIDED; THEREFORE, NO INVESTIGATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A PATIENT HAD EXPERIENCED A CHEMICAL BURN AND AN INTENSE BURNING PAIN FROM EXPOSURE TO CAVICIDE. THE COMPLAINANT ALLEGED THAT A DOCTOR AND A NURSE IN THE EMERGENCY ROOM AT UNIVERSITY MEDICAL CENTER (UMC) HAD SPRAYED CAVICIDE DIRECTLY INTO HIS OPEN WOUND MULTIPLE TIMES BEFORE SUTURES WERE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803110 CAVICIDE SURFACE DISINFECTANT LRJ METREX RESEARCH

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| O