BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADS - PEDIATRIC

    MDR report key: 3043404 · Received March 11, 2013

    Report

    Report Number
    1218950-2013-00850
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    March 5, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K992543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED REDDENING TO THE SKIN. THE PATIENT WAS TREATED WITH TOPICAL CREAM AND THE SKIN HEALED WITHOUT FURTHER TREATMENT. THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED REDDENING TO THE SKIN. THE PATIENT WAS TREATED WITH TOPICAL CREAM AND THE SKIN HEALED WITHOUT FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102714 PADS - PEDIATRIC MKJ PHILIPS MEDICAL SYSTEMS M3717A

    Patients

    Seq Age Sex Outcome Treatment
    1