Brand Name | REVITIVE IX |
Type of Device | CIRCULATION BOOSTER |
Manufacturer (Section D) |
ACTEGY LTD |
reflex |
cain road |
bracknell, berkshire RG12 1HL |
UK RG12 1HL |
|
Manufacturer (Section G) |
MIRAE MEDI & TECH CO., LTD |
22 baekseokgongdan 5-gil |
seobuk-gu, cheonan city |
chungnan, |
KS
|
|
Manufacturer Contact |
lawrence
brookfield
|
reflex |
cain road |
bracknell,, berkshire RG12 -1HL
|
UK
RG12 1HL
|
|
MDR Report Key | 7552167 |
MDR Text Key | 109481799 |
Report Number | 3010078417-2018-00002 |
Device Sequence Number | 1 |
Product Code |
NUH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K143207 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Remedial Action |
Patient Monitoring |
Type of Report
| Initial |
Report Date |
05/30/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/30/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | IX |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Event Location |
Home
|
Date Manufacturer Received | 10/20/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|