BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPREP PASTE

    MDR report key: 164620 · Received April 20, 1998

    Report

    Report Number
    1718791-1998-00002
    Event Type
    Other
    Date Received
    April 20, 1998
    Date of Event
    November 1, 1997
    Report Date
    April 20, 1998
    Manufacturer
    WEAVER AND CO.
    Product Code
    GYB
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT IN SURGERY FOR CERVICAL TRAUMA SURGERY. C1, C2 FUSION. EVOKED POTENTIAL MONITORING ELECTRODES PLACE ON HEAD AND SCALP. ELECTRODE AT CZ (CENTER TOP OF SCALP) IRRITATED AFTER SURGERY AND DID NOT HEAL PROPERLY. APPEARS THAT PERMANENT DAMAGE TO HAIR FOLLUCULES MAY HAVE OCCURRED AND THAT HAIR IN THIS SPOT MAY NOT GROW BACK. ESTIMATED AREA ABOUT 10-15 MM IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPREP PASTE ABRASIVE SKIN PREP PASTE GYB WEAVER AND CO. 10-10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other EC2 PASTE (11/1997 TO 11/1997).