BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMA S T.E.N.S

    MDR report key: 3763966 · Received April 1, 2014

    Report

    Report Number
    MW5035738
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    PAIN TECHNOLOGIES
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE END RESULT OF MANUALLY OPERATING WHEELCHAIR MOBILITY AID FOR NINE AND ONE HALF YEARS EACH DAY. I WAS NOT ABLE TO FORESEE IN ADVANCE I WAS ABOUT TO CAUSE SEVERE INJURY OF THE TWO HANDS, THE IMPAIRMENT CONDITION OF THE TWO HANDS AND OF THE FEET. NO IMPROVEMENT. THE CONDITION HAS WORSENED. THE IMPAIRMENT CONDITION IS NOT KNOWN TO IMPROVE. THE DEVICE WAS OF (B)(6) PHYSICAL THERAPY CLINIC. NO REPLY APPROX 5.5 MONTHS. THE CONSUMER CONTACT TELEPHONE NUMBER INCLUDED. THE DEVICE IS EFFECTIVE FOR ACUTE PAIN CONTROL WITHIN THE LOCATION OF WHERE THE ELECTRODE CONTACTS WOULD BE ATTACHED, STATIC, PHYSICAL IMMOBILE POSITION. A MOBILE POSITION, NUMBER. I DO TRY TO REDUCE THAT PHYSICAL ACTIVITY TO ABSOLUTE BARE MINIMUM EACH DAY. STRENUOUS PHYSICAL ACTIVITY CAUSES ALL SORTS OF MAJOR COMPLICATIONS THAT DO NOTHING AT ALL BUT AGGRAVATE CHRONIC PAIN MANAGEMENT ISSUE, QUITE CONSIDERABLY. THE TWO RED LED INDICATORS DO NOT INDICATE IF AND WHEN THE TWO AA ELECTRIC BATTERIES WOULD BE OF SAFE MAXIMUM ELECTRIC POWER. ONE MAJOR UNSAFE FEATURE OF THE OVERALL OPERATION OF THE DEVICE. THE TWO RED LED INDICATORS DO NOTHING AT ALL OTHER THAN TO INDICATE THAT THE ELECTRIC BATTERY RECHARGER COMPONENT IS CONNECTED TO THE DC ELECTRIC POWER SOURCE. A MULTI-COLOR INDICATOR SHOULD HAVE BEEN INCLUDED AND NOT EXCLUDED TO INDICATE THE SAFE MAXIMUM RECHARGE OF THE AA ELECTRIC BATTERIES, TO UP RATE THE OVERALL OPERATION OF THE DEVICE. THE DEVICE IS UNSAFE TO OPERATE. THE DEVICE WAS NOT ONLY UNSAFE, THE DEVICE WAS DEFECTIVE, AND OF A SUBSTANDARD QUALITY.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON 09/17/2014. MY PERSONAL SUBJECTIVE OPINION OF THE DEVICE. THE DEVICE WAS NOT ONLY UNSAFE TO OPERATE, THE DEVICE WAS OF A SUBSTANDARD QUALITY. SO I DID SUGGEST A TECHNOLOGY EVAL AT THE DEVICE. HAS THAT BEEN AT ALL REALIZED? IF SO? THE PRODUCT STATUS OF THE ULTIMA S T. E. N. S., DEVICE? THE VERY BEST TO YOURS, AND TO YOU. I MOST CERTAINLY WOULD APPRECIATE SOME SORT OF A FAVORABLE REACTION, AND A REPLY ALSO.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM REPORTER ON 04/18/2014: I ALSO DID SUGGEST THAT A TECH SAFETY INTO DATA EVAL OF THE DEVICE BE CONDUCTED. I AM AN EXPERIENCED OPERATOR OF THE DEVICE. I DID NOT MOST DEFINITELY PURPORT MYSELF TO HAVE BEEN SOME SORT OF A QUALIFIED TECHNICIAN. QUITE TO THE CONTRARY. I AM THE UNSKILLED LAYMAN. THAT'S NOT ONLY A TRUE PERSONAL STATEMENT OF HEAVIEST FACT. THAT IS ALSO GENUINE HUMILITY. THE INSTRUCTION GUIDE INCLUDED. A NUMBER OF WHOLLY UNSAFE, AND MAJOR SAFETY ISSUES, EXCLUDED, SOME HOW. THE INCOMPLETE ADDRESS INCLUDED. NO KNOWN INTERNET INTO SAFETY TECH DATA SEARCH AVAILABLE. NO KNOWN INFO SAFETY TECH DATA WEB SITE SEARCH OPTION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193206 ULTIMA S T.E.N.S TENS DEVICE GZJ PAIN TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 *