BEUDAMED
    FDA Adverse Event Summary report: N

    VENOSCOPE

    MDR report key: 6152554 · Received December 7, 2016

    Report

    Report Number
    2319429-2016-00001
    Date Received
    December 7, 2016
    Product Code
    HJN
    PMA / PMN Number
    K951422
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED PACKAGE OF TWO NT01 NEONATAL TRANSILLUMINATORS FROM (B)(6), BIOMED, ON 10/20/2016 STATING THAT HE HAD A COMPLAINT THAT ONE OF THE TWO LIGHTS HAD CAUSED A BURN, BUT THE STAFF WAS NOT SURE WHICH ONE. MR. (B)(6) STATED THAT HE HAD SEEN THE BABY WHEN HE PICKED UP THE LIGHTS AND THE "BURN" APPEARED TO BE MINOR SHOWING A SMALL REDDISH AREA. BOTH UNITS WERE TESTED, USING TIME/TEMP METHOD, AND WERE FOUND TO BE WELL WITHIN THE SAFE RANGE WHEN USED ACCORDING TO THE CAUTION LABEL WHICH STATES THAT "DO NOT LEAVE LIGHT ON BABY'S SKIN FOR AN EXTENDED PERIOD OF TIME (4 MINUTES OR MORE). CHECK FREQUENTLY FOR ANY HEAT BUILDUP DUE TO EXTENDED USE". THE UNIT WAS "ON SKIN OFF/ON FOR 2 MINUTE PERIOD" WHICH, ACCORDING TO TESTS, WOULD NOT HAVE GENERATED SUFFICIENT HEAT TO HARM THE BABY. THEY DID NOT STATE HOW MANY 2 MINUTE PERIODS IT WAS USED OR HOW LONG THE LIGHT WAS ALLOWED TO COOL BETWEEN USES. RETURNED BOTH LIGHTS TO (B)(6), BIOMED, ALONG WITH THE TIME/TEMP STUDIES AND A COMPLAINT DISPOSITION FORM.

    Description of Event or Problem · 1

    SEE USER FACILITY DESCRIPTION OF EVENT PREVIOUSLY SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803537 VENOSCOPE NEONATAL TRANSILLUMINATOR HJN

    Patients

    Seq Age Sex Outcome Treatment
    1