BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPACK

    MDR report key: 2000536 · Received February 18, 2011

    Report

    Report Number
    2000536
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDLINE
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS GIVEN A PERINEAL COLD/WARM PACK BY THE STUDENT NURSE POST PARTUM. PT DEVELOPED A BURN WITH A BLISTER ON HER RIGHT INNER THIGH WHICH PT STATED WAS CAUSED FROM THE PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPACK PACK, HOT OR COLD, DISPOSABLE IMD MEDLINE * *
    2 PERIPACK PACK, HOT OR COLD, DISPOSABLE IMD HOSPITAL MARKETING SERVICES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR