BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAEMOLANCE LANCET

    MDR report key: 2251940 · Received September 16, 2011

    Report

    Report Number
    1832816-2011-00071
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    February 15, 2010
    Report Date
    September 7, 2011
    Manufacturer
    HTL-STREFA S.A.
    Product Code
    FMK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARKRAY RECEIVED A LETTER FROM (B)(6) IN REFERENCE TO CLAIM (B)(4). THIS CLAIM STATED THAT EMPLOYEE MS. (B)(6) RECEIVED A PUNCTURE WOUND FROM A LANCET THAT DID NOT RETRACT FOR PRODUCT # 990500. THE LETTER STATED THAT DUE TO THE PUNCTURE THE EMPLOYEE WAS EXPOSED TO THE (B)(6) AS THE PATIENT SHE WAS ATTENDING TO CARRIES (B)(6). MS. (B)(6) WAS REQUIRED TO UNDERGO TESTING BY AN INFECTIOUS DISEASE DOCTOR AND HAS COMPLETED TREATMENT. ARKRAY HAS ATTEMPTED TO GATHER FURTHER INFORMATION, BUT REPORTER AND PATIENT HAVE NOT RESPONDED WITH FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAEMOLANCE LANCET LANCET FMK HTL-STREFA S.A. 990500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening