MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-05-29 for REVITIVE IX manufactured by Actegy Ltd.
[109391511]
After several attempts to contact the customer (mr (b)(6)) customer care managed to contact the mr (b)(6) on april 13, 2018 and confirmed the following: a) he had never visited his doctor or hospital concerning this reported incident. B) that he was suffering from poor circulation and had a self-expanding stent system put in and was not overweight. C) he had spoken to customer care on how best use the device, use lotion, keep hydrated and not turn the device up too high. D) admitted that initially he had not used the device correctly turning the intensity up too high. Following his conversation with customer care he was now using the device correctly as specified in the ifu to avoid a similar recurrence. E) his doctor is happy that his circulation has improved and that he continues to use the device.
Patient Sequence No: 1, Text Type: N, H10
[109391512]
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: customer reported "electric shock in his left foot that was painful and it also happened with the replacement. Right at the end of his big toe and after about ten minutes of use when he was on the phone with customer care. When he first used the replacement machine he suffered the shock sensation immediately. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010078417-2018-00001 |
| MDR Report Key | 7549033 |
| Report Source | CONSUMER |
| Date Received | 2018-05-29 |
| Date of Report | 2018-05-29 |
| Date of Event | 2016-09-12 |
| Date Added to Maude | 2018-05-29 |
| 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 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REVITIVE IX |
| Generic Name | CIRCULATION BOOSTER |
| Product Code | NUH |
| Date Received | 2018-05-29 |
| Model Number | IX |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 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 | 2018-05-29 |