BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIMBL PNEUMATIC COMPRESSION SYSTEM

    MDR report key: 23544376 · Received November 12, 2025

    Report

    Report Number
    MW5178833
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    September 16, 2025
    Report Date
    November 8, 2025
    Manufacturer
    TACTILE MEDICAL TECHNOLOGY, INC.
    Product Code
    JOW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS ORDERED/USED A NIMBL PNEUMATIC COMPRESSION SYSTEM FOR BIL LE- STARTING 08/21X 4 DAYS - BID PRESSURE LVL2. THE CLOSEST COMPARISON IS A PAIR OF SNOWSUIT PANTS CONNECTED TO A PUMP FOR 60 MINUTES PER SESSION APPLYING SEGMENTAL PRESSURE UP THE LENGTH OF YOUR LEG. FEELS LIKE A GENTLE SQUEEZING MASSAGE. USE WAS THEN HALTED DUE TO LEG CONDITION 08/25 AND RESUMED 09/10 BUT TOQD/PRESSURE LVL1 X1 THEN BID LVL2 AS ORDERED. BY 09/15 A SERIES OF DEVICE FAILURES OCCURRED. THE INITIAL FAILURE WAS THE PUMP HAD REALLY HIGH PRESSURE TO MY LEGS AND THERAPY SESSIONS WERE ENDED PREMATURELY. THE PUMP BEGAN APPLYING SO MUCH PRESSURE THAT MY LEGS WERE FIRMLY EXTENDED BUT MY FEET FORCED INTO A POINTED POSITION WITH TOES LEVEL WITH FLOOR. IT WAS SO MUCH PRESSURE THAT YOU COULDN'T MOVE/REPOSITION YOUR LEG IN THE SLEEVE AND IT WAS VERY UNCOMFORTABLE. EACH TIME I CALLED TO MY SPOUSE TO RESCUE ME AND IMMEDIATELY DEFLATE THE DEVICE. THIS WAS NOT SOMETHING I COULD GET TO QUICKLY AS THE PATIENT IN THE DEVICE. NEXT THE PUMP HAD SO MUCH PRESSURE THAT THE L LEG SLEEVE/GARMENT SPONTANEOUSLY INFLATED TO THE POINT THAT THE THIGH TO ANKLE-LEVEL ZIPPER SECURING THE GARMENT COMPLETELY UNZIPPED DURING THERAPY CAUSING THE GARMENT TO POP OPEN AND OFF THE EXTREMITY. THE LEG SLEEVE THEN POPPED OPEN LIKE A "HOT DOG BUN" WITH THE INNER SIDES FIRMLY FILLED AND RIGID. THIS OCCURRED WHILE MY LEG WAS IN THE DEVICE. THE FINAL FAILURE WAS THE DEVICE APPLYING SO MUCH PRESSURE THAT THE THIN SILKEN PANTS I HAD ON (HAD TO HAVE A BARRIER LAYER WHEN IN PUMP PER REP) LEFT DEEP INDENTATIONS, VALLEYS AND RIDGES EVIDENT ON MY SKIN, A PRESSURE SPOT WAS EVIDENT ON MY LEFT SHIN THAT OPENED INTO A NEW LEG ULCER AFTER USE. THE RAISED AREAS REMAINED PRESENT FORT 60+ MINUTES. PICS TAKEN. THE DEVICE REP WAS IMMED. CONTACTED BY TEXT + EMAIL TO THE COMPANY ABOUT THE PROBLEMS. THE COMPANY THEN HAD ME DO PRODUCT TESTING AT HOME PER THEIR INSTRUCTIONS (TIME 5+ HRS). ADDITIONAL PRODUCT FAILURES LIKE THOSE I EXPERIENCED OCCURRED. THE COMPANY TOLD ME A BUTTON SEQUENCE TO PUSH TO LIGHT "ERROR LIGHTS" ON THE DEVICE WHICH ALSO WERE PRESENT. ONE REP STATED THIS WAS A PRESSURE ERROR WARNING LIGHT. THE INITIAL TEST- THE PUMP WOULD NOT INITIATE WHEN BOTH LEG SLEEVES WERE CONNECTED. THEN DIRECTED TO TEST THE LEGS INDEPENDENTLY. ONE TEST HAD THE DEVICE EXERT SO MUCH PRESSURE THAT THE ZIPPER UNZIPPED FROM TOP TO BOTTOM JUST AS IT HAD ON MY LEG. THE LEG ULCER REQUIRED CARE BY A SPECIALIST AND AN ADDITIONAL WEEKLONG MEDICAL SPECIALTY DRESSING. I HAD BEEN DISCHARGED FROM CARE JUST DAYS PRIOR. LEG WOUNDS ARE OF PARTICULAR CONCERN GIVEN THAT I AM DIABETIC AND IMMUNOSUPPRESSED FROM LONGTERM, CHRONIC, HIGH DOSE STEROIDS AND CVID. THE COMPANY FIRST OFFERED TO REPLACE THE LEG SLEEVES AND THEN OFFERED TO CHANGE THE PUMP. I LOST ALL CONFIDENCE IN THE SAFETY OF THE PRODUCT BASED ON MY EXPERIENCE AND REQUESTED AND GOT AN APPROVED RETURN. THE COMPANY APPROVED AND PAID FOR THE RETURN VIA FEDEX. AT NO TIME DID THEY COMMUNICATE VERBALLY/IN WRITING THAT THE RETURN WAS CONDITIONAL. THEY STATED PRODUCT TESTING WOULD OCCUR. THE EQUIPMENT WAS RETURNED IN GOOD FAITH AND RECEIVED BY THE COMPANY. TODAY THEY CONTACTED ME STATING THAT THE PATIENT BALANCE OF $157 WAS DUE AND A LETTER TO THAT EFFECT WOULD BE SENT TO MY HOME. THE STATED THEIR CALL WAS A COURTESY IN ADVANCE OF THAT LETTER. WHEN ASKED THEY ALSO STATED THAT (B)(6) HAD ALSO BEEN BILLED AND PAID $1063 AND THAT THE BILLING WOULD STAND EVEN THOUGH I NO LONGER HAD, POSSESSED, OWNED NOR HAD ACCESS TO THE DEVICE. IN ESSENCE THEY WILL BE BILLING ME FOR A PRODUCT I DO NOT HAVE AND A PRODUCT THAT CAUSED AN INJURY THAT NEEDED CARE. THEY STATED A "MGMT COURTESY" WOULD BE EXTENDED TO SHIP ME A NIMBL PUMP. IT WAS UNCLEAR IF THAT MEANT THE RELATED SUPPLIES LIKE THE TUBING AND LEG SLEEVES AND IF A NEW OR THE SAME ONE THAT FAILED. HOWEVER, AT THIS POINT, MY PROVIDER HAS ORDERED A DIFFERENT DME PROVIDER FOR THIS TREATMENT AS I HAVE BEEN WITHOUT IT TILL NOW. THEY ARE SENDING A CLARIFICATION LETTER WITH WHAT THE MANAGEMENT COURTESY ENTAILS. SHIPPING A PUMP IN ISOLATION WILL NOT ALLOW ME TO HAVE THE TREATMENT MY DOCTOR HAS ORDERED. ADDITIONALLY, I DO NOT HAVE ANY CONFIDENCE IN THE SAFETY OF THIS EQUIPMENT AND HAVE HAD QUESTIONABLE CUSTOMER SERVICE AFTER THE ISSUE WHICH ONLY STRENGTHENS MY OPINIONS. ADDITIONALLY, THE COMPETITOR HAS A MUCH BETTER PRODUCT DESIGN- BOTH IN OVERINFLATION PROTECTION AND IN THE DESIGN AND FIT OF THE LEG SLEEVES. THE PRIOR PRODUCT FROM TACTILE MEDICAL HAD INTERNAL ZIPPER CONFIGURATIONS WITHIN THE SLEEVES THAT PRESSED HARD INTO THE SKIN OF THE AREA AND EVEN MORE SO WHEN THE EXCESSIVE PRESSURE I EXPERIENCED HAPPENED. THE FACT THAT I HAD TO SEE ADDED CARE MEANT ADDED COSTS TO TOE ME AND MY INSURER/MEDICARE. THE FACT THAT TACTILE IS PRESSURING ME FOR PAYMENT FOR AN ITEM I DO NOT HAVE NOR HAVE ACCESS TO IS CONCERNING. THEY ALSO STATED THAT THE BILLING TO (B)(6)/MEDICARE STANDS EVEN THOUGH I DO NOT HAVE A DEVICE WITH WHICH TO COMPLETE THERAPY. LUCKILY THE CARE RECEIVED WAS A " AND IMMEDIATE SAME DAY ADD ON" WITH WOUND CARE SO ANY PERMANENT HARM SEEMS TO HAVE BEEN AVOIDED. I AM VERY CONCERNED ABOUT BOTH THE FUNCTION OF THE PRODUCT AND THE FACT THAT I AM BEING BILLED FOR A FAILED PRODUCT. I AM LOOKING FOR ASSISTANCE AND CONCERNED ABOUT OTHER PATIENTS WHO MAY BE AT RISK. HAD I BEEN ALONE OR IN SOME WAY COMPROMISED IN TERMS OR LEVEL OF ALERTNESS ETC OR WORSE SKIN ISSUES, HARM MAY HAVE BEEN A REAL CONCERN. THANKFULLY MY SPOUSE WAS AVAILABLE TO GET THE GARMENT OFF ASAP THUS MINIMIZING THE HARM THAT OCCURRED. I DON'T FULLY UNDERSTAND WHY THE COMPANY IS PRESSURING ME FOR PAYMENT AND MAKING ME FEEL LIKE I AM BEING FORCED TO TAKE/USE THEIR PRODUCT WHEN MY PROVIDER HAS ORDERED SOMETHING MORE APPROPRIATE FOR MY NEEDS. PLEASE LET ME KNOW IF ADDED INFORMATION IS NEEDED. APPROVED RETURN BY COMPANY SO EQUIPMENT TO THEM. PHOTOS AND TEST DATA TO COMPANY. HAVE EMAIL CONVOS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141054 NIMBL PNEUMATIC COMPRESSION SYSTEM SLEEVE, LIMB, COMPRESSIBLE JOW TACTILE MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention ALBUTEROL PRN/SYMBICORT PRN,| BELSOMRA, | BIPAP, | CALCIUM, | CANE OR WHEELED WALKER BASED ON MOBILITY ISSUES | CGM- LIBRE3| CONTINUOUS OXYGEN,| CYMBALTA, | DUONEB PRN, | EQIQUIS, | FLOMAX, | FOSAMAX, | HYDROCORTISONE, | IMPLANTED PAIN PUMP WITH INTRATHECAL MORPHINE, | IMPLANTED PAIN PUMP, | IMPLANTED PORTACATH, | IVIG INFUSIONS, | JARDIANCE, | LIDEX CREAM, | LIPITOR, | LYRICA, | MELATONIN CBD,| METOPROLOL,| MURPRICON CREAM, | MVI, | NEBULIZER - PRN URI, | NEXIUM, | OXEMPIC, | OXYGEN, | PHENERGAN PRN.| POTASSIUM TIZANIDINE,| TERRAIN MEDS- LA + SA INSULIN, | TORSEMIDE, | TYLENOL PRN.| VIT C, | VITAMIN D3, | VOLTAREN GEL,