BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPITAL TEMP PUMP PROFESSIONAL

    MDR report key: 6169103 · Received December 13, 2016

    Report

    Report Number
    0001831750-2016-00397
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 15, 2016
    Report Date
    March 23, 2018
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT WAS BURNT DURING A HOUR AND A HALF SURGERY. THE ACCOUNT DID NOT CHECK THE PATIENT'S SKIN CONDITION AT ANY POINT DURING THE SURGERY. THE OPERATORS MANUAL INDICATES THAT THE PATIENT'S SKIN CONDITION SHOULD BE CHECKED EVERY 30 MINUTES. INSERVICES TO TRAIN NURSES ON PROPER PROCEDURES FOR T-PUMPS ARE IN ORDER TO MITIGATE CHANCES OF REOCCURRENCE. DEVICE NOT RETURNED

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO INCLUDE UDI. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ALLEGEDLY RECEIVED A BURN USING A TEMPERATURE THERAPY PAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ALLEGEDLY RECEIVED A BURN USING A TEMPERATURE THERAPY PAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ALLEGEDLY RECEIVED A BURN USING A TEMPERATURE THERAPY PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821474 CAPITAL TEMP PUMP PROFESSIONAL PACK, HOT OR COLD, WATER CIRCULATING ILO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1