BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCUTHERM4 THERAPY DEVICE

    MDR report key: 8588165 · Received May 7, 2019

    Report

    Report Number
    1648700-2019-00002
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    March 4, 2019
    Report Date
    May 7, 2019
    Manufacturer
    THERMOTEK, INC.
    Product Code
    JOW
    PMA / PMN Number
    K061866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    SALES REP RECEIVED EMAIL (B)(4) 2019 WITH QUESTIONS ABOUT HOW A DVT/PE COULD DEVELOP; EMAIL WAS FORWARDED TO QUALITY, WHO IMMEDIATELY REQUESTED THAT UNIT BE RETURNED FOR EVALUATION AND AN ALLEGED PATIENT INJURY FORM BE COMPLETED; CUSTOMER DID NOT RESPOND TO REQUESTS; REPEATED REQUESTS FOR ADDITIONAL INFORMATION WERE MADE, WITH NO RESPONSE. BASED ON LIMITED INFORMATION (QUESTION PRESENTED), WE COULD NOT DETERMINE IF OUR DEVICE CAUSED OR CONTRIBUTED TO POSSIBLE INCIDENT. WE COULD NOT EVEN CONCLUDE THAT AN INCIDENT OCCURED. WE ARE FILING A REPORT AS A CAUTIONARY MEASURE ONLY.

    Description of Event or Problem · 1

    UPON SERVICE: SEE DOCUMENTS (RX AND LMN FOR COLD/COMPRESSION). (B)(6) YEAR OLD FEMALE; LEFT LEG TKR (B)(6) 2018; PHYSICIAN PRESCRIBED COLD/COMPRESSION/DVT POST OPERATIVELY FOR 30 DAYS; ACTUAL USAGE 67 DAYS; COLD PRESCRIBED AT 45 ON/45 OFF; NO SPECIFIC TEMPERATURE 4-5 TIMES PER DAY; MMHG OF STANDARD COMPRESSION NOT SPECIFIED 4-5 TIMES PER DAY; DVT PROPHYLAXIS (L VS R VS BILATERAL) NOT SPECIFIED BUT WRS SETUP THE PATIENT BILATERAL CALF. DVT ONLY SPEC'D 4-5 TIMES PER DAY; PREAUTH & REIMBURSEMENT DENIED BY THE INSURANCE CARRIER; WRS FIT THE PATIENT ANYWAYS NO DVT RISK PROFILE ASSESSMENT COMPLETED PRIOR TO SURGERY. DAY 10-14- AT APPROXIMATELY DAY 10-14, PATIENT PRESENTED TO TREATING PHYSICIAN WITH SWELLING IN THE LEGS, HEAT AND REDNESS; "PHYSICIAN COMMENTED BEGINNING SIGNS OF DVT DEVELOPMENT" FOLLOWING THIS PRESENTATION, PHYSICIAN DID NOT DISCONTINUE THE USE OF DVT PROPHYLAXIS DATE TBD (ESTIMATED SOMETIME IN MID JANUARY); PATIENT DISCHARGED FROM WRS SERVICE; TOTAL RUN HOURS OVER 67 DAYS = 300 +/- UNIT IS NOW ON ANOTHER PATIENT. (B)(6) 2019- PATIENT PRESENTED YESTERDAY WITH MULTIPLE DVTS IN BOTH LEGS AND A PULMONARY EMBOLISM PHYSICIAN'S STAFF CONTACTED WRS' REPRESENTATIVE - "HOW DID THIS PATIENT GET A DVT/PE IF THEY WERE USING A VASCUTHERM?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378303 VASCUTHERM4 THERAPY DEVICE VT4 THERAPY DEVICE JOW THERMOTEK, INC. VT4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other