BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV PREP WIPES

    MDR report key: 2146742 · Received June 30, 2011

    Report

    Report Number
    1017593-2011-00001
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    January 10, 2011
    Report Date
    June 30, 2011
    Manufacturer
    WOUND US MANUFACTURING SITE
    Product Code
    NEC
    Removal / Correction Number
    3006760724-030211-001R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IV PREP COMPLAINT WAS RECEIVED POST SMITH & NEPHEW¿S REMEDIAL ACTION (VOLUNTARY RECALL) TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO THE PUBLIC HEALTH (REF RECALL #3006760724-030211-001R). THIS EVENT IS CURRENTLY UNDER INVESTIGATION AND MEDICAL REVIEW. INVESTIGATION RESULTS TO BE SUBMITTED IN A SUPPLEMENT REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING REPORT INVOLVING IV PREP WIPES WAS RECEIVED POST SMITH & NEPHEW'S REMEDIAL ACTION (VOLUNTARY RECALL) TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO THE PUBLIC HEALTH (REF RECALL #3006760724-030211-001R). PATIENT HOSPITALIZED IN JANUARY FOR A BACTERIAL INFECTION. VOMITING DEHYDRATED WENT IN TO KETOACIDOSIS - BLOOD COUNT SHOWED BACTERIAL INFECTION. TREATED THE SUGARS FIRST, THE PUMP WAS REMOVED WHEN SHE ENTERED THE HOSPITAL. THEY DID NOT FIND THE SOURCE OF THE INFECTION. WAS IN INTENSIVE CARE. THEY DID NOT TREAT WITH ANTIBIOTICS. HOSPITALIZED FROM JANUARY 10 -12. RESUMED USING THE PUMP THE NIGHT RELEASED TO GO HOME. STILL HAS TIMES SHE FEELS NAUSEA AND DOES NOT FEEL GOOD. SHE DOES NOT HAVE THE BOX OR ANY OF THE IV PREP WIPES LEFT FROM THAT BOX. SHE ASKED HER DOCTOR TODAY IF THIS COULD HAVE BEEN THE CAUSE OF THE BACTERIAL INFECTION FROM JANUARY, AND HE SAID YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IV PREP WIPES IV PREP WIPES BOX OF 50 NEC WOUND US MANUFACTURING SITE 59421200 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization