BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVIWIPES

    MDR report key: 2991056 · Received March 6, 2013

    Report

    Report Number
    1722021-2013-00007
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    METREX RESEARCH
    Product Code
    LRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMPLOYEE HAD RINSED HER EYE WITH COPIOUS AMOUNTS OF WATER; HOWEVER, SHE WAS STILL EXPERIENCING IRRITATION. DURING A FOLLOW UP PHONE CALL ON (B)(4) 2013 WITH THE AFFECTED EMPLOYEE, IT WAS REVEALED THAT SHE HAD SOUGHT MEDICAL ATTENTION WITH A DOCTOR AND WAS GIVEN OVER THE COUNTER EYE DROPS (SYSTANE) FOR TREATMENT. THE EMPLOYEE CONFIRMED THAT SHE IS DOING FINE AND HAS FULLY RECOVERED. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT WHILE AN EMPLOYEE WAS PULLING A TOWELETTE OUT FROM THE CAVIWIPES CANISTER, THE SOLUTION HAD SPLASHED INTO HER EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95819 CAVIWIPES DISINFECTANT, MEDICAL DEVICES LRJ METREX RESEARCH 12-2298NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R