BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUPREP SKIN PREP GEL

    MDR report key: 6353023 · Received February 23, 2017

    Report

    Report Number
    1718791-2017-00002
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    January 19, 2017
    Report Date
    February 23, 2017
    Manufacturer
    D. O. WEAVER AND COMPANY
    Product Code
    DRX
    PMA / PMN Number
    K885306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTED FOLLOW-UP WITH PATIENT MULTIPLE TIMES, BUT NO RESPONSE. IT IS A KNOWN FACT THAT A VERY SMALL PERCENTAGE OF THE POPULATION WILL REACT NEGATIVELY TO TOPICAL PRODUCTS. BASED ON THE INFORMATION PROVIDED, PATIENT MAY HAVE EXPERIENCED AN ALLERGIC REACTION TO NUPREP AND/OR TEN20. WITHOUT FURTHER INFORMATION, WE CANNOT DETERMINE A MORE DEFINITIVE CAUSE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, WE WILL FILE A FOLLOW-UP REPORT. DEVICE NOT AVAILABLE TO PATIENT.

    Description of Event or Problem · 1

    PT HAD SLEEP STUDY AT (B)(6). PT EXPERIENCED BURNING SENSATIONS AND ITCHING WHERE THE ELECTRODES WERE ATTACHED ON HER HEAD. SHE AWOKE AT 3:30AM AND ASKED FOR HELP, BUT THE MEDICAL TECHNOLOGIST WOULD NOT LET HER USE A SHOWER TO RINSE HER HAIR. SHE LEFT THE HOSPITAL AND WENT HOME TO WASH HER HAIR. SHE THEN DISCOVERED BURN-LIKE SPOTS AND MISSING HAIR WHERE THE ELECTRODES WERE PLACED. SHE SAW A DERMATOLOGIST, WHO TOLD HER THAT SHE HAD "3RD DEGREE ACTION" TO GEL/PASTE. DERMATOLOGIST GAVE HER CREAM TO PUT ON SCABS AND MEDICATED SHAMPOO, AND ADVISED HER NOT TO USE ANY OTHER HAIR PRODUCTS UNTIL SHE WAS COMPLETELY HEALED. PT SAID SHE ADVISED THE TECH THAT SHE HAD VERY SENSITIVE SKIN AND WAS SENSITIVE TO TAPE ADHESIVE. TECH TOLD HER THE TAPE WAS NON-SENSITIVE AND THAT SHE WOULD NOT HAVE ANY PROBLEMS WITH THE TAPE. PT NOT COMPLETELY SURE WHAT PRODUCTS WERE USED DURING THE SLEEP STUDY, BUT MIGHT HAVE BEEN NUPREP AND/OR TEN20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135618 NUPREP SKIN PREP GEL SKIN PREPPING GEL DRX D. O. WEAVER AND COMPANY 10-30

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other TEN20 CONDUCTIVE PASTE