BEUDAMED
    FDA Adverse Event Other Summary report: N

    READYBATH SHAMPOO CAP

    MDR report key: 541922 · Received July 22, 2004

    Report

    Report Number
    541922
    Event Type
    Other
    Date Received
    July 22, 2004
    Date of Event
    July 17, 2004
    Report Date
    July 22, 2004
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FYF
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ONE OF THE NURSES NOTED THAT THE INSTRUCTIONS ON THE READYBATH SHAMPOO CAP INDICATE THE CAP CAN BE HEATED IN THE MICROWAVE FOR NO MORE THAN 30 SECONDS, BUT DOES NOT INDICATE AT WHAT TEMPERATURE. THE INSTRUCTIONS CAUTION THAT HEATING TIME MAY VARY ACCORDING TO WATTAGE. THE COMPANY ASKED FOR ADDITIONAL GUIDANCE FROM THE LOCAL REPRESENTATIVE, AND WAS GIVEN TWO OPTIONS: 1) HEAT IN AN 800 WATT MICROWAVE FOR NO MORE THAN 30 SECONDS, OR 2) HEAT IN THE MICROWAVE WARMERS PROVIDED BY MEDLINE. THE COMPANY WILL SUGGEST INCLUDING THE RECOMMENDED WATTAGE IN THE INSTRUCTIONS TO GIVE USERS SOME SORT OF GUIDELINE AS TO DURATION OF HEATING BASED ON THE STRENGTH OF THEIR MICROWAVE IF THEY ARE NOT USING THE MANUFACTURER'S WARMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 READYBATH SHAMPOO CAP DISPOSABLE SHAMPOO CAP FYF MEDLINE INDUSTRIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *