MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-05-30 for REVITIVE IX manufactured by Actegy Ltd.
[109481799]
Unfortunately following the death of the customer no further information could be obtained.
Patient Sequence No: 1, Text Type: N, H10
[109481800]
Please note: following an fda inspection at actegy ltd between (b)(6) 2018 by mr (b)(6) it was identified this incident should have been reported to fda. Therefore, the following incident is being reported retrospectively: the patient notified actegy on the (b)(6) 2016 that he had received an electric shock from the device. Following the fda finding an attempt was made to contact the customer but we were told that sadly he had died (but not as a result of the revitive ix circulation booster). Actegy customers are typically aged 70+ and this occasionally happens.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010078417-2018-00002 |
| MDR Report Key | 7552167 |
| Report Source | CONSUMER |
| Date Received | 2018-05-30 |
| Date of Report | 2018-05-30 |
| Date of Event | 2016-10-20 |
| Date Mfgr Received | 2016-10-20 |
| Date Added to Maude | 2018-05-30 |
| 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, CHEONAN CITY |
| Manufacturer City | CHUNGNAN, |
| Manufacturer Country | KS |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REVITIVE IX |
| Generic Name | CIRCULATION BOOSTER |
| Product Code | NUH |
| Date Received | 2018-05-30 |
| Model Number | IX |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2018-05-30 |