BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPERATURE THERAPY PAD

    MDR report key: 6669353 · Received June 27, 2017

    Report

    Report Number
    0001831750-2017-00271
    Event Type
    Injury
    Date Received
    June 27, 2017
    Date of Event
    March 4, 2017
    Report Date
    January 24, 2018
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFECTS WERE ALLEGED WITH THE PRODUCT, A CONVERSATION BETWEEN THE CUSTOMER AND STRYKER ACCOUNT MANAGER IDENTIFIED THAT THIS ISSUE IS LIKELY ATTRIBUTED TO THE CUSTOMER NOT BEING AWARE TO CHECK THE PATIENT'S SKIN EVERY 30 MINUTES AS DIRECTED BY THE OPERATIONS MANUAL. THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY THE ACCOUNT MANAGER WORKING WITH THE CUSTOMER TO OFFER CONTINUOUS TRAINING TO MITIGATE THE CHANCES OF REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REVIEWED REGARDING THIS EVENT. IT WAS IDENTIFIED THAT UNLESS THERE WAS A SPECIFIC PRODUCT MALFUNCTION, THE BURN WAS LIKELY MISIDENTIFIED. FOR A BURN TO OCCUR, THE PRODUCT WOULD NEED TO BE AT LEAST 44° C. WITHOUT A FAILURE OF THE BACKUP AND PRIMARY THERMOSTATS, THE HIGHEST TEMPERATURE THE T-PUMP CAN REACH IS 42 ° C. IT IS LIKELY THAT THE INJURY WAS MISIDENTIFIED BY THE CUSTOMER. THIS INJURY WAS MOST LIKELY A SOFT-TISSUE INJURY. THIS CAN BE ATTRIBUTED TO MECHANICAL FORCES (SUCH AS PRESSURE OR SHEER) CREATED BY THE 8002-062-022 PAD.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT WHILE A NURSE WAS USING A T-PUMP ON A PATIENT, THE PATIENT DEVELOPED BLISTERS/SORES ON THEIR SKIN.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT WHILE A NURSE WAS USING A T-PUMP ON A PATIENT, THE PATIENT DEVELOPED BLISTERS/SORES ON THEIR SKIN.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT WHILE A NURSE WAS USING A 8002-062-022 WITH A T-PUMP ON A PATIENT, THE PATIENT DEVELOPED BLISTERS/SORES ON THEIR SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450705 TEMPERATURE THERAPY PAD PACK, HOT OR COLD, WATER CIRCULATING ILO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4), TEMPERATURE THERAPY PAD