MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-10-05 for REVITIVE ARTHRITIS KNEE 2836AA manufactured by Actegy Ltd.
[122800759]
A female customer ((b)(6)) used the device on tuesday (b)(6) 2018 in the morning and began to feel chest pains on tuesday evening. She went to the doctors on wednesday morning and the doctor called an ambulance for her to go to (b)(6) hospital in (b)(6). They confirmed that she had a heart attack and did an angiogram. The hospital confirmed that (b)(6) had a heart attack. Subsequently after leaving hospital the customer suffered another heart attack on (b)(6) 2018. Customer questionnaire completed over the telephone with the help of her daughter ((b)(6)) on (b)(6) 2018. Device returned to actegy ltd and tested on 1 october 2018 and tested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010078417-2018-00009 |
| MDR Report Key | 7937855 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-05 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-08-21 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-10-05 |
| 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 AND 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 ARTHRITIS KNEE |
| Generic Name | CIRCULATION BOOSTER |
| Product Code | NGX |
| Date Received | 2018-10-05 |
| Returned To Mfg | 2018-09-28 |
| Model Number | REVITIVE ARTHRITIS KNEE |
| Catalog Number | 2836AA |
| 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; 2. Life Threatening | 2018-10-05 |