BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACE LARGE REUSABLE COLD COMPRESS

    MDR report key: 2094156 · Received May 4, 2011

    Report

    Report Number
    9710505-2011-00001
    Event Type
    Other
    Date Received
    May 4, 2011
    Date of Event
    November 17, 2010
    Report Date
    February 25, 2011
    Manufacturer
    RAPID AID CORP
    Product Code
    IME
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HE WENT TO HIS DERMATOLOGIST (DR. (B)(6)) ON (B)(6) 2010 AND THE DOCTOR PRESCRIBED A CREAM (OXISTAT CREAM 1% - OXICONAZOLE NITRATE CREAM 60G) AND PILLS (GRIS-PEG 250MG TABLETS). THE DOCTOR IS UNSURE OF THE DIAGNOSIS. SINCE HE SAW THE DOCTOR, IT HAS NOT SHOWN ANY SIGNS OF HEALING EXCEPT FOR THE FACT THAT IT DOES NOT ITCH AS MUCH. BAG WITH PART # (B)(4) HAD NOT BEEN USED AT RAPID AID SINCE 2005. A REVIEW OF COMPLAINTS INDICATED THAT NONE HAVE BEEN RECENTLY REC'D RELATED WITH FUNGAL INFECTION OR RING WORM. SINCE LOT# AND SAMPLE HAD NOT BEEN PROVIDED, WE HAVE NOT BEEN ABLE TO GATHER ADD'L INFO. TEAM WILL CONTINUE TO MONITOR FOR ANY FUTURE COMPLAINTS RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    A MALE PT HAS BEEN USING THE REUSABLE COLD COMPRESS FOR ABOUT 5 OR 10 YEARS EVERY WEEK, BUT ON APPROX (B)(6) 2010, THE LOWER AREA ON HIS BACK STARTED TO GET DRY ITCHY SKIN SHOW RED SPOTS WHICH THE CUSTOMER SAID RESEMBLED RINGWORM. HE WEARS THE PRODUCT FOR 10-15 MINUTES AT A TIME. HE WRAPS THE COMPRESS IN A TOWEL PRIOR TO APPLYING IT TO THE SKIN, SO THERE IS NO DIRECT CONTACT. THE SPOTS ON HIS BACK DO NOT HURT, BUT THEY ITCH. IT IS ALL OVER HIS LOWER BACK AND HAS EVEN SHOWN UP ON HIS BUTTOCKS. THE RED MARKS ARE NOT IN THE SHAPE OF THE COLD COMPRESS AND IT HAS SPREAD OVER AN AREA LARGER THAN THE ACTUAL PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE LARGE REUSABLE COLD COMPRESS IME RAPID AID CORP X78106 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other