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 DX 2694 manufactured by Actegy Ltd.
[109647065]
Patient outcome: patient treated with stent implant, recovering at home following hospital discharge 5 days after the incident. Patient corrective action: patient has discontinued use of the device. Manufacturer's preliminary analysis: device has been returned for testing and was found to be operating within intended specification. Initial corrective action: device returned for investigation. Further information requested to enable thorough investigation and medical opinion to be sought.
Patient Sequence No: 1, Text Type: N, H10
[109647066]
Customer purchased the device (b)(6) 2017 for diabetic neuropathy. Used the device for the 2nd time on (b)(6) 2017, settings unknown. On the morning of (b)(6) 2017, jr suffered a heart attack and was hospitalised. Treatment included stent implant, specific location of stent unknown. (b)(6) discharged from hospital (b)(6) 2017. Recovering well at home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010078417-2018-00008 |
| MDR Report Key | 7556818 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-05-31 |
| Date of Report | 2018-05-31 |
| Date of Event | 2017-03-06 |
| Date Mfgr Received | 2016-04-11 |
| Device Manufacturer Date | 2015-08-22 |
| 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 DX |
| Generic Name | CIRCULATION BOOSTER |
| Product Code | NUH |
| Date Received | 2018-05-31 |
| Returned To Mfg | 2017-03-17 |
| Model Number | REVITIVE DX |
| Catalog Number | 2694 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization | 2018-05-31 |