BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXITOUCH PLUS SYSTEM

    MDR report key: 11174946 · Received January 14, 2021

    Report

    Report Number
    3004183730-2021-00002
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    December 15, 2020
    Report Date
    December 15, 2020
    Manufacturer
    TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL
    Product Code
    JOW
    UDI-DI
    00816305023381
    PMA / PMN Number
    K170216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE USING THE PD32-G3 THE PATIENT DEVELOPED A PULMONARY EMBOLISM. PER THE PATIENTS SON, THE MD'S HAVE INSTRUCTED THE PATIENT TO HOLD USE OF THE PD32-G3 AT THIS TIME BUT THEY "DID NOT KNOW WHAT THE EMBOLISM IS FROM". PER TACTILE MEDICAL'S CHIEF MEDICAL OFFICER THE PD32-G3 WOULD NOT CAUSE OR CONTRIBUTE TO THE DEVELOPMENT OF A DVT HOWEVER WITHOUT CONFIRMATION FROM THE PATIENTS MD'S THAT THIS PRODUCT CAUSED OR CONTRIBUTED TO THE PULMONARY EMBOLISM THIS IS BEING REPORTED AS A POSSIBLE CAUSE. THE DEVICE PERFORMED AS INTENDED, THERE WERE NO DEVICE DEFECTS REPORTED BY THE USER.

    Description of Event or Problem · 1

    THE PATIENT WAS SHIPPED A PD32-G3 CONTROLLER, SERIAL NUMBER (B)(4), A HALF LEG REGULAR LEFT GARMENT 3L-HL-RG-L LOT 117327 AND A HALF LEG REGULAR RIGHT GARMENT 3L-HL-RG-R LOT 117328 ON (B)(6) 2020. ON (B)(6) 2020 IT WAS REPORTED BY THE PATIENT'S SON THAT THE PATIENT NORMALLY HAS SHORTNESS OF BREATH BUT IT HAS BEEN WORSE WITH USE OF THE PD32-G3. TACTILE MEDIAL ADVISED THE PATIENT NOT USE THE PD32-G3 UNTIL APPROVED BY THE PATIENTS HCT. ON (B)(6) 2020 TACTILE MEDICAL FOLLOWED UP WITH THE PATIENT AND SPOKE TO THE PATIENTS SON WHO STATED THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 AND TREATED FOR A PULMONARY EMBOLISM AND WAS DISCHARGED HOME ON (B)(6) 2020 WITH OXYGEN AND HOME NURSING / THERAPY SERVICES (NOTE: TACTILE MEDICAL HAS BEEN COMMUNICATING WITH TWO DIFFERENT FAMILY MEMBERS: ONE FAMILY MEMBER REPORTED PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2020 FOR BLOOD CLOTS IN LUNGS. SECOND FAMILY MEMBER STATED THIS TOOK PLACE ON (B)(6) 2020). PER THE PATIENTS SON, THE MD'S HAVE INSTRUCTED THE PATIENT TO HOLD USE OF THE PD32-G3 AT THIS TIME BUT THEY "DID NOT KNOW WHAT THE EMBOLISM IS FROM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66325 FLEXITOUCH PLUS SYSTEM PNEUMATIC COMPRESSION DEVIC JOW TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL PD32-G3 117327, 117328 00816305023381

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R