BEUDAMED
    FDA Adverse Event Summary report: N

    NON-STERILE GLOVE

    MDR report key: 12041 · Received March 15, 1994

    Report

    Report Number
    MW1001087
    Date Received
    March 15, 1994
    Date of Event
    January 31, 1994
    Report Date
    February 24, 1994
    Manufacturer
    PHARMASEAL DIV. BAXTER HEALTHCARE CORP.
    Product Code
    LYY
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT RETURNED GLOVE TO HOSP PHARMACY, INDICATING HE SUSPECTED CONTAMINATION OF PRODUCT. ONLY ONE GLOVE WAS RETURNED, NOT THE ORIGINAL BOX. PT INDICATED HE HAD BEEN USING GLOVES FOR BOWEL CARE AND HAD NOT ENCOUNTERED ANY PROBLEMS. PT REQUESTED THAT THE RPTR ANALYZE SUSPECTED GLOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-STERILE GLOVE LYY PHARMASEAL DIV. BAXTER HEALTHCARE CORP. N3C040

    Patients

    Seq Age Sex Outcome Treatment
    1 *