BEUDAMED
    FDA Adverse Event Other Summary report: N

    HLYWOG 2.471X3.198 GELPAD 10PK

    MDR report key: 3688128 · Received February 26, 2014

    Report

    Report Number
    2183164-2014-00002
    Event Type
    Other
    Date Received
    February 26, 2014
    Report Date
    February 6, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A GEL PAD. THE DISTRIBUTOR STATES THAT (B)(4) RECEIVED A COMPLAINT ON (B)(6) 2014 FROM A CUSTOMER WITH A SKIN RASH FROM USE OF THE WITOUCH TENS DEVICE AND THE WITOUCH GEL-PADS MANUFACTURED BY COVIDIEN. HE REPORTED HE HAS OWNED HIS WITOUCH BRAND TENS UNIT FOR ABOUT FOUR MONTHS. AT MONTH THREE ((B)(6) 2013) HE NOTICED ITCHING BENEATH THE WITOUCH GEL-PADS HYDROGEL PADS DURING AND AFTER USE OF THE TENS UNIT. THE CUSTOMER HAPPENS TO BE A MEDICAL DOCTOR, AND SOUGHT MEDICAL ATTENTION FROM A DERMATOLOGIST. HE DISCONTINUED USE FOR APPROXIMATELY TWO WEEKS AND APPLIED CORTISONE CREME PRESCRIBED BY THE DERMATOLOGISTS. DURING THIS TIME THE SKIN RASH CLEARED UP, AND RECENTLY WHEN HE TRIED TO USE THE TENS UNIT AND GEL-PADS AGAIN THE RASH BEGAN TO RETURN. HE NOW HAS COMPLETELY STOPPED USE. HE REPORTED WITOUCH GEL-PADS LOT# 300423 WAS USED DURING THE TIME THE SKIN RASH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119148 HLYWOG 2.471X3.198 GELPAD 10PK GEL PAD GZJ COVIDIEN PC90036 300423

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other