BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUPREP SKIN PREP GEL

    MDR report key: 3232371 · Received December 10, 2012

    Report

    Report Number
    1718791-2012-00014
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    September 14, 2012
    Report Date
    December 10, 2012
    Manufacturer
    D.O. WEAVER CO.
    Product Code
    DRX
    PMA / PMN Number
    K885306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPOKE WITH PT ON (B)(4) 2012. SHE STATED THAT HER SKIN HAS BEGUN TO HEAL AND HAD A FOLLOW UP APPT WITH DERMATOLOGIST ON (B)(6) 2012. DERMATOLOGIST DIAGNOSED PT WITH IRRITANT DERMATITIS. PT STILL EXPERIENCES DISCOMFORT AT ELECTRODE SITES, BUT BELIEVES IT IS GETTING BETTER. PT WILL FOLLOW UP WITH US IF HER CONDITION CHANGES.

    Description of Event or Problem · 1

    PT CALLED TO REQUEST A COPY OF MSDS FOR NUPREP AND TEN20. SHE STATED THAT SHE RECENTLY SUFFERED INJURIES DURING A RECENT LONG-TERM NEURODIAGNOSTIC EXAM AT THE EEG LAB AT (B)(6) HOSPITAL IN (B)(6). DURING THE EXAM PREP ON (B)(6) 2012, PT NOTICED THE TECH SPRAY A SOLUTION CALLED NEUTRAL QUAT DISINFECTANT CLEANER CONCENTRATE ON THE ELECTRODES USED FOR HER EXAM. AFTERWARD, PT'S SKIN WAS PREPPED WITH NUPREP SKIN PREP GEL. DURING THIS TIME, PT TOLD THE TECH THAT SHE WAS SCRUBBING TOO HARD. THE EXAM PROCEEDED AND TEN20 CONDUCTIVE PASTE WAS USED INSIDE THE ELECTRODES, PRESSED ONTO THE SKIN, AND COLLODION WAS USED TO FURTHER ATTACH THE ELECTRODES. FINALLY, THE PT'S HEAD WAS WRAPPED TO HOLD EVERYTHING IN PLACE. PT SPENT SEVERAL DAYS IN PAIN, AND BURNING AN DITCHING WERE REPORTED BY THE PT TO THE (B)(6) LAB. ELECTRODES WERE REMOVED ON (B)(6) 2012, AND THE PT NOTED THAT COLLODION REMOVER WAS USED TO ASSIST IN REMOVING THE ELECTRODES. PT STATED THAT AT THIS TIME, THE BURNING INTENSIFIED. PT BELIEVES THAT A COMBINATION OF PRODUCTS AND MISUSE CAUSED HER INJURIES. PT STATED THAT SHE HAD BURNS, BLISTERS, AND RED SWOLLEN SKIN. PT WENT TO URGENT CARE ON (B)(6) 2012 AND WAS GIVEN A TOPICAL CREAM. ON (B)(6) 2012, PT VISITED PCP. PCP TOLD HER, SHE HAD ALLERGIC DERMATITIS AND REFERRED HER TO A DERMATOLOGIST. PT VISITED DERMATOLOGIST ON (B)(6) 2012. DERMATOLOGIST PRESCRIBED A DIFFERENT TOPICAL CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUPREP SKIN PREP GEL SKIN PREPPING GEL DRX D.O. WEAVER CO. 10-30

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention TEN20 CONDUCTIVE PASTE| COLLODION| NEUTRAL QUAT DISENFECTANT CLEANER CONCENTRATE| COLLODION REMOVER