BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINIPAD ALCOHOL PREP, ANTISEPTIC

    MDR report key: 276020 · Received April 26, 2000

    Report

    Report Number
    1036962-2000-00002
    Event Type
    Injury
    Date Received
    April 26, 2000
    Date of Event
    February 7, 2000
    Report Date
    April 12, 2000
    Product Code
    LKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO EMERGENCY ROOM WITH INFECTION CULTURED AS PSEUDOMONAS AERUGINOSA AFTER PROCEDURE PERFORMED ON RIGHT FOOT. PT HAD RECEIVED CLINIPAD ALCOHOL PREP PRIOR TO INFECTION OF PRE-OP. LOCAL INFILTRATION OF MEDS. SURGERY 2/7/00 - SEEN IN ER 2/19/00 WITH SWOLLEN RIGHT FOOT; RED LEG. ORAL ANTIBIOTICS. ON 2/24 HOSPITALIZED WITH CULTURE OF PSEUDOMONAS AERUGINOSA. HOSPITALIZED WITH ANTIBIOTICS 5 DAYS. DISCHARGED 2/29/00. IS IN WOUND CARE PROGRAM. 3/30 MILD FEVER; CELLULITIS RESOLVING. STILL CONTINUE HYPERBARIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINIPAD ALCOHOL PREP, ANTISEPTIC ALCOHOL PREP PAD LKB NA 813169,818761,900580,(MORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R