BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXITOUCH SYSTEM

    MDR report key: 2261859 · Received September 19, 2011

    Report

    Report Number
    3004183730-2011-00001
    Event Type
    Injury
    Date Received
    September 19, 2011
    Date of Event
    June 12, 2011
    Report Date
    August 22, 2011
    Manufacturer
    TACTILE SYSTEMS TECHNOLOGY INC
    Product Code
    IRP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DOES NOT BELIEVE THE COMPLICATIONS EXPERIENCED BY THE PT SUBSEQUENT TO USE OF THE FLEXITOUCH DEVICE ARE THE RESULT OF THE FLEXITOUCH. THE PT HAS AN EXTENSIVE MEDICAL HISTORY OF RELATED ISSUES INCLUDED A PREVIOUS AMPUTATION. IN ADDITION, THE PT DID NOT REPORT ANY DISCOMFORT OR PAIN ASSOCIATED WITH THE 3 TREATMENTS HE HAD WITH THE DEVICE. THE TUBES ASSOCIATED WITH FEMORAL POPLITEAL ARTERIAL BYPASS ARE NOT LIKELY TO BE DAMAGED BY THE MILD PRESSURES EXERTED BY THE FLEXITOUCH DEVICE. IN ADDITION, THE PT HAD RECENT COMPRESSION WITH COMPRESSION CUFFS AND TOURNIQUETS DURING HIS RECENT SURGERIES. THE TREATING CLINICIAN HAS NOT BEEN ABLE TO ASCERTAIN THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE CLINICAL COMPLICATIONS OF THE PT.

    Description of Event or Problem · 1

    PT CALLED INDICATING THAT HE HAD BEEN SEEN BY A VASCULAR SURGEON FOR PROBLEMS RELATED A LOSS OF BLOOD FLOW TO HIS RIGHT FOOT. THE PHYSICIAN ASSESSED THAT THE TUBE THAT HAD BEEN PLACED IN THE PT'S RIGHT LEG DURING A FEMORAL-POPLITEAL ARTERIAL BYPASS IN (B)(6) 2010 WAS BLOCKED OR CRUSHED. THE PT WAS PRESCRIBED THE FLEXITOUCH IN (B)(6) 2011 TO ADDRESS LYMPHEDEMA SECONDARY TO CVI. ON (B)(6) 2011, HE WAS TRAINED ON THE FLEXITOUCH DEVICE. HIS TRAINING WAS UNEVENTFUL. HE HAD 3 TREATMENTS BETWEEN (B)(6) 2011. HE HAS NOT USED THE DEVICE SINCE THAT TIME, EVEN THOUGH HIS TREATMENT PRESCRIPTION INDICATED DAILY ONE HOUR TREATMENTS. BASED ON HIS CURRENT COMPLICATIONS RELATED TO THE BLOCKAGE OF THE ARTERIAL TUBE, THE PHYSICIAN INSTRUCTED THE PT TO STOP USING THE FLEXITOUCH DEVICE. THE PHYSICIAN HAS NOT BEEN ABLE TO DETERMINE THE CAUSE OF THE DAMAGE TO THE ARTERIAL TUBE. SINCE RECEIVING THE DEVICE, THE PT HAS HAD MULTIPLE SURGERIES WHEREIN A COMPRESSION CUFF AND TOURNIQUET WERE UTILIZED. THE PT INDICATED THAT THE PHYSICIAN THOUGHT THAT THE COMPRESSION CUFF AND/OR TOURNIQUET MAY HAVE CONTRIBUTED TO THE CRUSHING OF THE ARTERIAL TUBE. THE PT WAS BEING SCHEDULED FOR SURGERY RELATED TO THE COMPLICATIONS ASSOCIATED WITH HIS POOR VASCULAR CONDITION AND WAS BEING ASSESSED FOR FURTHER, MORE PROXIMAL AMPUTATION. WHEN CONTACTED DIRECTLY BY THE COMPANY, THE PHYSICIAN COULD NOT ASSESS ONE WAY OR THE OTHER WHETHER THE FLEXITOUCH DEVICE HAD ANY IMPACT ON THE DAMAGED ARTERIAL TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXITOUCH SYSTEM POWERED INFLATABLE TUBE MASSAGER IRP TACTILE SYSTEMS TECHNOLOGY INC PD32-U

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention