BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPREP

    MDR report key: 269151 · Received March 9, 2000

    Report

    Report Number
    1718791-2000-00001
    Event Type
    Other
    Date Received
    March 9, 2000
    Date of Event
    December 2, 1999
    Report Date
    February 28, 2000
    Manufacturer
    WEAVER AND CO
    Product Code
    LRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED A DIME-SIZED SCAR ON MID-FOREHEAD AFTER UNDERGOING "SCALP STUDY", ACCORDING TO THE RISK MGR OF THE HOSP. THE STUDY WAS MORE ACCURATELY DESCRIBED AS A SLEEP STUDY. PT IS AFRICAN-AMERICAN EMPLOYEE OF THE HOSP. HAS A DARKER SPOT ON THE FOREHEAD. PT DID NOT COMPLAIN THE DAY OF THE TEST, HOWEVER PT DEVELOPED A RED SPOT THAT STARTED TO SCAB IN 2 OR 3 DAYS. PT SAW DERMATOLGIST AND SURGEON (DATES AND INFO UNK) ACCORDING TO THE RESPIRATORY CARE SVCS DIR. PT HAD OTHER ELECTRODE PLACED AROUND THE SCALP, HOWEVER NO OTHER AREA HAD A SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPREP ABRASIVE SKIN PREP PASTE LRY WEAVER AND CO 4 OZ BOTTLE OCT 2001 01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other MEDITRACE LOT # 931218 EXP 12/2000