BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITIVE MEDIC

    MDR report key: 7556167 · Received May 31, 2018

    Report

    Report Number
    3010078417-2018-00006
    Event Type
    Injury
    Date Received
    May 31, 2018
    Date of Event
    May 15, 2017
    Report Date
    May 31, 2018
    Manufacturer
    ACTEGY LTD
    Product Code
    NUH
    PMA / PMN Number
    K152480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE CURRENT LOCATION/DISPOSITION: THE PATIENT IS STILL USING THE DEVICE. PATIENT OUTCOME: PATIENT HAS MADE A FULL RECOVERY. REMEDIAL ACTION TAKEN BY THE HEALTHCARE FACILITY RELEVANT TO THE CARE OF THE PATIENT: FOLLOWING THE INCIDENT MR (B)(6) DECIDED TO VISIT HIS PHYSIOTHERAPIST TO GET SOME PAIN RELIEF; HOWEVER, THERE WAS NO SIGNIFICANT IMPROVEMENT IN HIS CONDITION. MR (B)(6) THEN VISITED HIS GP WHO REFERRED HIM FOR AN ULTRASOUND EXAMINATION WHICH CAME BACK NEGATIVE. AFTER THE EXAMINATION, MR (B)(6)REPORTED LOSING THE ABILITY TO WALK ON THE HEEL OF HIS RIGHT FOOT MAKING WALKING DIFFICULT. MR (B)(6) THEN MADE AN APPOINTMENT WITH HIS RHEUMATOLOGIST (DR. (B)(6)) ON THE (B)(6) 2017 WHO DIAGNOSED AN ELONGATION OF THE PERONEAL NERVE. DR. (B)(6) PRESCRIBED 12 PHYSIOTHERAPY SESSIONS WITH MASSAGE AND ELECTROSTIMULATION OF THE RIGHT PERONEAL NERVE. FURTHER ADVICE WAS PROVIDED BY MR (B)(6)'S ANGIOLOGIST WHO ADVISED HIM TO ONLY USE THE DEVICE AGAIN AFTER INITIAL WARM UP EXERCISES.

    Description of Event or Problem · 1

    PLEASE NOTE: FOLLOWING AN FDA INSPECTION AT ACTEGY LTD BETWEEN MARCH 5-8, 2018 BY MR (B)(6), IT WAS IDENTIFIED THIS INCIDENT SHOULD HAVE BEEN REPORTED TO FDA. THEREFORE, THE FOLLOWING INCIDENT IS BEING REPORTED RETROSPECTIVELY: MR (B)(6) REPORTED PAINS IN LEGS AND CALVES AND STATED THAT HE WAS NOT ABLE TO WALK FOLLOWING USE OF THE DEVICE AND THAT HE NO LONGER HAD CONTROL OF MUSCLES CONTROLLING HIS ANKLE. DOPPLER ULTRASOUND CONFIRMED NO CIRCULATION RELATED CAUSE. HOSPITAL RHEUMATOLOGIST HAS PRESCRIBED PHYSIOTHERAPY AND THE CUSTOMER IS NO LONGER EXPERIENCING ANY PROBLEMS AND EXISTING MEDICAL CONDITIONS ARE STILL TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400611 REVITIVE MEDIC CIRCULATION BOOSTER NUH ACTEGY LTD REVITIVE MEDIC

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention