BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUPREP GEL

    MDR report key: 2512323 · Received March 26, 2012

    Report

    Report Number
    1718791-2012-00005
    Event Type
    Injury
    Date Received
    March 26, 2012
    Date of Event
    February 28, 2012
    Report Date
    March 26, 2012
    Manufacturer
    D.O. WEAVER AND CO
    Product Code
    GYB
    PMA / PMN Number
    K885306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    F/U ON (B)(6) 2012, WITH TECH INDICATED THAT THE PT WAS INDEED FINE AFTER THE EPINEPHRINE SHOT. THE TECH BELIEVES THAT PT MUST BE ALLERGIC TO SOMETHING IN NUPREP, AND THIS IS WHAT CAUSED THE SKIN HIVES AND DIFFICULTY BREATHING.

    Description of Event or Problem · 1

    PT EXPERIENCED HIVES AND DIFFICULTY BREATHING AFTER NUPREP WAS APPLIED TO SKIN. TECH HAD DONE A PRE-TEST OF NUPREP ON PT'S SKIN AND PT HAD NO REACTIONS. THEN ABOUT 20 MINUTES INTO THE TEST, PT STARTED FORMING HIVES, BUT SAID SHE WAS FINE. SOON AFTER, PT EXPERIENCED TROUBLE BREATHING AND WAS TAKEN TO (B)(6). FROM THERE SHE WAS TAKEN TO THE HOSP, WHERE SHE WAS ADMINISTERED AN EPINEPHRINE SHOT. PT WAS FINE AFTER THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUPREP GEL NUPREP GYB D.O. WEAVER AND CO 10-30 593

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other