BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6003 LG BABY SHADE 50/B 200/C

    MDR report key: 5442236 · Received February 17, 2016

    Report

    Report Number
    9681860-2016-00001
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    January 14, 2016
    Report Date
    February 5, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FOK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 02/17/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE SAMPLE RECEIVED WITH THIS COMPLAINT CONSISTED OF ONE UNOPENED POUCH WITH PHOTOTHERAPY EYE PROTECTOR (LARGE) PART NUMBER: MI00625. THE UNUSED MI00625 PART WAS 100% VISUALLY INSPECTED AND MET ALL REQUIREMENTS OF PRODUCT CONSTRUCTION. CONSEQUENTLY THE REPORTED CONDITION COULD NOT BE CONFIRMED. THE OBSERVED RATE OF OCCURRENCE FOR THIS ISSUE DOES NOT EXCEED THE EXPECTED RATE OF OCCURRENCE AS DOCUMENTED IN THE RISK MANAGEMENT FILE. THE MOST PROBABLE ROOT CAUSE OF PHOTOTHERAPY GLASSES NOT FITTING TO THE OCULAR AREA IS IN IMPROPER USE OF THE PRODUCT. IT IS WORTH NOTING THAT PAYING STRICT ATTENTION TO PRODUCT APPLICATION UTILIZING BOTH THE HYDROGEL AND PROVIDED HEADBAND STRAPS IN THE CORRECT POSITIONING AS IDENTIFIED ON THE POUCH WILL INCREASE PRODUCT EFFICACY. IT IS IMPORTANT TO NOTE THAT COVIDIEN OFFERS TWO SIZES OF BABY SHADES: SMALL (PRODUCT ID MI00575) AND LARGE (PRODUCT ID MI00625). THIS CUSTOMER COMPLAINT IS ON THE LARGE BABY SHADES WHICH IS MEANT TO BE USED ON LARGER BABIES AND NOT ON SMALLER PREMATURE BABY. THE SMALL SIZE OF BABY SHADES IS 2.9CM X 11.4 CM, WHEREAS THE LARGE IS 3.8CM X 14CM. THE LARGER SIZE OF BABY SHADES IS MADE TO FIT ON BIGGER BABIES. ADDITIONALLY, AS IDENTIFIED ON THE INSERT PROVIDED WITH THE PRODUCT IT IS A SINGLE USE PRODUCT AND IS NOT DESIGNED FOR RE-APPLICATIONS. SINCE THIS COMPLAINT IS UNCONFIRMED AND NO COMPLAINT TREND EXISTS AND A SPECIFIC ROOT CAUSE FOR THE OCCURRENCE CANNOT BE IDENTIFIED, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS COMPLAINT WILL BE RECORDED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A BABY SHADE. THE CUSTOMER REPORTS THAT THE PHOTOTHERAPY GLASSES DO NOT FIT TO THE OCULAR AREA SO THEY DO NOT PROTECT THE PATIENT FROM THE HARMFUL EFFECTS CAUSED BY PHOTOTHERAPY. THE PHOTOTHERAPY GLASSES ARE STUCK ON THE BABY'S SKIN AND THEY HAVE TO UNSTICK THEM EVERY 3 HOURS WHEN THE BABY IS FED. SOMETIMES PHOTOTHERAPY GLASSES ALSO STICK AND IS DANGEROUS TO THE PREMATURE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99720 6003 LG BABY SHADE 50/B 200/C BABY SHADE FOK COVIDIEN MI00625 525801X

    Patients

    Seq Age Sex Outcome Treatment
    1