BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECARE ACTIVECARE+SFT

    MDR report key: 5489205 · Received March 9, 2016

    Report

    Report Number
    9616558-2016-00001
    Event Type
    Injury
    Date Received
    March 9, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 8, 2016
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS DBN LTD.
    Product Code
    JOW
    PMA / PMN Number
    K151377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE, SLEEVES AND POWER SUPPLY WERE TESTED AND FOUND TO BE FUNCTIONAL PER SPECIFICATIONS, DEVICE PASSED ALL TESTS. THE OPERATION AND SERVICE MANUAL (UM A358A-0017-01_REV04) ALONG WITH THE PATIENT INSTRUCTION FOR USE (PM_A385A-0018-01_REV04) INDICATE THAT: CAUTION: INSPECT PATIENT'S LEG(S) UNDER TREATMENT AT LEAST ONCE A DAY FOR SIGNS OF PATHOLOGICAL SKIN CHANGES. CAUTION: INSPECT LEGS OF HIGH-RISK PATIENTS AT LEAST THREE TIMES A DAY. DOUBLE CHECK THE POSITIONING AND PROPER ADJUSTMENT OF THE SLEEVE BEFORE AND DURING DEVICE OPERATION. HIGH-RISK PATIENTS INCLUDED - ELDERLY; DEBILITATED; PARALYZED; UNCONSCIOUS; WITH DIFFUSE MALIGNANCY; WITH SEVERE PERIPHERAL NEUROPATHIES; KNOWN SEVERE ARTERIAL VASCULOPATHY OR PATIENTS WITH CONTINUOUS EPIDURAL ANALGESIA. PER COMMUNICATION WITH THE MD, THE PATIENT WAS NOT INSPECTED PER OUR RECOMMENDATION ABOVE AND INFECTION WAS FOUND BY THE MD AFTER A FEW DAYS POST SURGERY, AND THE SLEEVES WERE FOUND TO BE TIGHT ON THE LEG AND IT WAS VERY SWOLLEN. MCS FAILURE MODE OF "NO FAILURE FOUND" WAS ASSIGNED AND MCS ROOT CAUSE CODE OF "NO FAILURE FOUND" WERE ASSIGNED TO THIS COMPLAINT AS THERE IS ZERO INDICATION IN ANY CORRESPONDENCE WITH THE MD THAT THE DEVICE HAD MALFUNCTIONED IN ANY WAY. BASED ON THE ABOVE COMMENTS WE HAVE COME TO THE CONCLUSION THAT THERE WAS NO DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    PATIENT (B)(6) WENT IN FOR TOTAL RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2016, AND WAS GIVEN THE HOMECARE ACTIVECARE+SFT DEVICE THAT SAME DAY TO USE ON HIS CALF. THE HEALTHCARE PROFESSIONAL AND THE MD GAVE HIM INSTRUCTIONS ON HOW TO USE THE DEVICE, THE MD DID NOT PLACE THE STOCKINETTE AS IT IS OPTIONAL FOR ADDITIONAL COMFORT. WHILE THE PATIENT WAS STILL HOSPITALIZED, ON (B)(6) 2016 WHEN CHECKED BY THE MD, THE LEG LOOKED FINE. ON (B)(6) 2016 THE MD WAS OUT AND ANOTHER MD VISITED THE PATIENT AND FAILED TO LOOK AT THE LEG. ON (B)(6) 2016 THE ORIGINAL MD CHECKED THE LEG AND DISCOVERED THE PATIENT DEVELOPED BLISTERS UNDER THE SLEEVE. THE LEG WAS SWOLLEN AND THE SLEEVE WAS ON VERY TIGHT. THE HOMECARE ACTIVECARE+SFT UNIT WAS REMOVED ON POST-OPERATIVE DAY FOUR AND THE MD PRESCRIBED ANTI-CLOT MEDICATION (LOVENOX) PROPHYLACTICALLY FOR DVT. ON FOLLOW UP (B)(6) 2016 THE BLISTERS WERE STILL PRESENT AND SOME HAD REDNESS AROUND THEM. THE MD PRESCRIBED ORAL ANTIBIOTICS FOR CELLULITIS AND SUSPECTED UTI FOR 7 DAYS. THE MD ORDERED 3 ULTRASOUNDS TO RULE OUT DEEP VEIN THROMBOSIS(DVT), BECAUSE THE RADIOLOGIST WAS NOT ABLE TO VISUALIZE THE DEEP VEINS IN THE CALF. NO CLOTS WERE FOUND. ON (B)(6) 2016 A PATIENT FOLLOW UP VISIT DETERMINED THE BLISTERS HAD DRIED UP AND HAD SCABS AND THE SWELLING HAD DECREASED BUT THE LEG WAS NOT BACK TO NORMAL BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144458 HOMECARE ACTIVECARE+SFT COMPRESSIBLE LIMB SLEEVE JOW MEDICAL COMPRESSION SYSTEMS DBN LTD. HOMECARE ACTIVECARE+SFT N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention