MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-11-08 for REVITIVE MEDIC 2469MD 2616 manufactured by Actegy Ltd.
[126503188]
The revitive medic has a user interface and remote control which the user can increase or decrease the stimulation intensity. The device is designed so that stimulation intensity can only be increased in steps of 10. For example, if the customer wanted to increase the intensity from 10 to 99 by keeping his finger on the remote control as claimed by the customer he would have had to take his finger off the button and then press it again to increase to the maximum intensity step of 20 and incrementally up to 90. The instructions for use clearly provides the following caution: please read the user's manual carefully before using this product be careful when applying stimulation over areas of skin that lack normal sensation. This product is not intended for use by persons with reduced physical, sensory or metal capabilities, unless they are supervised by a person responsible for their safety.
Patient Sequence No: 1, Text Type: N, H10
[126503189]
On october 19 customers son ((b)(6)) called to report his father ((b)(6)) attempted to use the device on september 30 but could not feel anything so turned the intensity up to 90 and then placed feet on machine. It was too powerful and caused him to fall and hit his head, causing him to have a stroke. When the device intensity was set to 60 the customer claimed he could not feel any stimulation and therefore kept his thumb on the remote control increasing the intensity to 90. The customer reported to be in generally good health but is suffering from neuropathy and unable to drive. Prior to the reported incident the customer reported using the device 3 times a week for 15 minutes at intensity setting 60. The son is now reporting his father has been put in an assisted care facility and medicare is handling as a case for abuse of the elderly. Customer looking for refund to help cover costs for assisted care expenses, stating that his father is in assisted care now only because the revitive machine caused him to fall and hit his head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010078417-2018-00013 |
| MDR Report Key | 8050231 |
| Report Source | FOREIGN |
| Date Received | 2018-11-08 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-09-30 |
| Date Mfgr Received | 2018-10-19 |
| Device Manufacturer Date | 2018-05-07 |
| Date Added to Maude | 2018-11-08 |
| 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 |
| 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 | MIRAE MEDI & TECH CO., LTD |
| Manufacturer Street | 22 BAEKSEOKGONGDAN 5-GIL, SEOBUK-GU, |
| Manufacturer City | CHEONAN-SI,, CHUNGCHEONGNAM-DO |
| 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 | CIRCUALTION BOOSTER |
| Product Code | NGX |
| Date Received | 2018-11-08 |
| Model Number | 2469MD |
| Catalog Number | 2616 |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | N |
| 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. Life Threatening | 2018-11-08 |