MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-05-31 for REVITIVE MEDIC manufactured by Actegy Ltd.
[109617961]
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.
Patient Sequence No: 1, Text Type: N, H10
[109617962]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010078417-2018-00006 |
| MDR Report Key | 7556167 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-05-31 |
| Date of Report | 2018-05-31 |
| Date of Event | 2017-05-15 |
| Date Mfgr Received | 2017-11-29 |
| Date Added to Maude | 2018-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LAWRENCE BROOKFIELD |
| Manufacturer Street | REFLEX CAIN ROAD |
| Manufacturer City | BRACKNELL, BERKSHIRE RG121HL |
| Manufacturer Country | UK |
| Manufacturer Postal | RG12 1HL |
| Manufacturer G1 | MIRA MEDI & TECH CO., LTD |
| Manufacturer Street | 22 BAEKSUK-DONG 5-GIL SEOBUK-GU |
| Manufacturer City | CHEONAN CITY, |
| Manufacturer Country | KS |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REVITIVE MEDIC |
| Generic Name | CIRCULATION BOOSTER |
| Product Code | NUH |
| Date Received | 2018-05-31 |
| Model Number | REVITIVE MEDIC |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACTEGY LTD |
| Manufacturer Address | REFLEX CAIN ROAD BRACKNELL, BERKSHIRE RG121HL UK RG12 1HL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-31 |