BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINAIR MEDSURG PULSE

    MDR report key: 2881527 · Received December 18, 2012

    Report

    Report Number
    1625774-2012-00083
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ARJOHUNTLEIGH, INC.
    Product Code
    IOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED BY THE MANUFACTURER ARJOHUNTLEIGH, INC. PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FROM THE MANUFACTURING SITE KINETIC CONCEPTS INC. AS OF (B)(6) 2012, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH INC. (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO ARJOHUNTLEIGH BY THE NURSE: ON (B)(6) 2012, THE HEATER WAS ON 55 DEGREES CENTIGRADE CAUSING THE PATIENT'S TEMPERATURE TO INCREASE AND SUBSEQUENT SKIN BREAKDOWN. ON (B)(6) 2012, ARJOHUNTLEIGH REGULATORY COMPLIANCE SPECIALIST SPOKE WITH THE RISK MANAGER WHO STATED THAT IT WAS UNDETERMINED HOW THE PATIENT DEVELOPED THE SKIN BREAKDOWN THAT WAS DESCRIBED AS AN UNSTAGEABLE PRESSURE ULCER ON THE SACRAL AREA. THE RISK MANAGER REPORTED THAT SHE WAS WAITING FOR A FINAL DEVICE EVALUATION BEFORE HER INVESTIGATION TO THE CAUSE OF THE PRESSURE ULCER COULD BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINAIR MEDSURG PULSE IOQ ARJOHUNTLEIGH, INC. 409000

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other