BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACK,HOT,INSTANT,NON-INSULATED,6"X10"

    MDR report key: 9312098 · Received November 12, 2019

    Report

    Report Number
    1417592-2019-00191
    Event Type
    Injury
    Date Received
    November 12, 2019
    Date of Event
    August 31, 2019
    Report Date
    November 12, 2019
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING MUSCLE SPASMS OF THE LEFT LEG WHILE IN THE HOSPITAL FOR AN UNRELATED ISSUE. THE NURSE REPORTEDLY USED HOT PACKS ON THE CUSTOMERS LEFT LOWER EXTREMITY WHICH, PER THE CUSTOMER'S FAMILY, RESULTED IN A BURN TO THE CUSTOMER'S LEFT ANTERIOR ANKLE THAT DID NOT HEAL. THE CUSTOMER'S FAMILY REPORTED THAT THE CUSTOMER DID NOT NOTICE THE BURN UNTIL AFTER RELEASE FROM THE HOSPITAL ((B)(6) 2019) AND THE FAMILY WAS TREATING THE WOUND AT HOME WITH NEOSPORIN WITHOUT SUCCESS. REPORTEDLY THE CUSTOMER'S FAMILY BROUGHT THE CUSTOMER TO THE PRIMARY CARE PHYSICIAN WHO ORDERED ORAL ANTIBIOTICS, HOWEVER THE CUSTOMER'S FAMILY DID NOT FEEL THE TREATMENT WAS APPROPRIATE SO THE FAMILY BROUGHT THE CUSTOMER TO THE HOSPITAL EMERGENCY DEPARTMENT THE SAME DAY ((B)(6) 2019). THE CUSTOMER WAS REPORTEDLY ADMITTED TO THE HOSPITAL WITH LEFT LOWER EXTREMITY ULCERATION FROM A BURN, WHICH SUBSEQUENTLY DEVELOPED CELLULITIS AND THE CUSTOMER WAS STARTED ON INTRAVENOUS ANTIBIOTICS INCLUDING VANCOMYCIN AND ZOSYN AS WELL AS WOUND CARE INCLUDING MEDIHONEY GEL AND OPTIFOAM. THE WOUND WAS REPORTEDLY IMPROVING. THE CUSTOMER WAS DISCHARGED HOME WITH FOLLOW UP HOME HEALTH SERVICES. THE FAMILY REPORTED THAT THERE IS NO SAMPLE AVAILABLE FOR EVALUATION, THE LOT NUMBER AND THE PRODUCT CODE ARE THE ASSUMED PRODUCT THAT MAY HAVE BEEN USED ON THE FAMILY MEMBER BECAUSE THAT IS THE PRODUCT THAT IS USED AT THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE. NO SAMPLE IS AVAILABLE FOR EVALUATION. DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING A HOT PACK, A CUSTOMER SUSTAINED A BURN TO THE LEFT ANTERIOR ANKLE RESULTING IN LOWER EXTREMITY ULCERATION WHICH SUBSEQUENTLY DEVELOPED CELLULITIS. THE CUSTOMER WAS ADMITTED TO THE HOSPITAL AND STARTED ON INTRAVENOUS ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107950 PACK,HOT,INSTANT,NON-INSULATED,6"X10" IMD MEDLINE INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R