BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTITOUCH, ACT-ADAPTIVE COMPRESSION THERAPY

    MDR report key: 5234030 · Received November 18, 2015

    Report

    Report Number
    3004183730-2015-00003
    Event Type
    Injury
    Date Received
    November 18, 2015
    Report Date
    November 18, 2015
    Manufacturer
    TACTILE SYSTEMS TECHNOLOGY, INC
    Product Code
    JOW
    PMA / PMN Number
    K071763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS BEEN UNABLE TO ASCERTAIN WHETHER THIS ADVERSE EVENT IS RELATED TO PNEUMATIC DEVICE USAGE. REPEATED INQUIRIES TO THE TREATING DOCTOR TO OBTAIN RELEVANT TREATMENT-RELATED INFORMATION HAVE NOT BEEN RETURNED. IN THE ABSENCE CLINICAL INFORMATION, THE RELEVANT DEGREE OF CAUSALITY CANNOT BE DETERMINED. SPECIFICALLY, THE CAUSE OF THE REPORTED AMPUTATION IS UNKNOWN (E.G., DEGREE OF ARTERIAL ISCHEMIA, VENOUS DISEASE, INFECTION AND CO-MORBID CONDITIONS). NO INFORMATION REGARDING THE RELATIONSHIP OF DEVICE USE TO THE AMPUTATION IS KNOWN (E.G., IT IS NOT KNOWN WHETHER THE PATIENT HAD BEEN USING THE PNEUMATIC DEVICE DURING THE TIME PERIOD OF THE AMPUTATION). DUE TO THE PHYSICIAN PROPOSED ADVERSE EVENT, AND DESPITE A GLOBAL LACK OF RELEVANT CLINICAL DATA, THIS REPORT IS BEING FILED. THE MANUFACTURER WILL CONTINUE TO SEEK ADDITIONAL INFORMATION AND, IF THIS BECOMES AVAILABLE, THE MANUFACTURER WILL AMEND THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED THE PNEUMATIC COMPRESSION DEVICE IN (B)(6) OF 2014. ON (B)(6) 2015, THE PATIENT'S PHYSICIAN STATED TO A MANUFACTURER REPRESENTATIVE THAT THE PATIENT REQUIRED A BELOW KNEE AMPUTATION. THE AMPUTATION OCCURRED SOMETIME AFTER THE PATIENT RECEIVED THE PNEUMATIC COMPRESSION DEVICE. THE PHYSICIAN INDICATED THAT HE THOUGHT THE NEED FOR THE AMPUTATION WAS DUE TO THE PNEUMATIC DEVICE "PUSHING OF FLUID INTO THE TOES" CAUSING INCREASED SWELLING. THE PHYSICIAN INDICATED THAT THE SWELLING EVENTUALLY LED TO THE AMPUTATION. THE EVENT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763940 ACTITOUCH, ACT-ADAPTIVE COMPRESSION THERAPY SLEEVE, LIMB, COMPRESSIBLE JOW TACTILE SYSTEMS TECHNOLOGY, INC ACTITOUCH

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Disability