Brand Name | MARK 5 NUVO |
Type of Device | GENERATOR, OXYGEN, PORTABLE |
Manufacturer (Section D) |
NIDEK MEDICAL PRODUCTS, INC. |
birmingham |
|
Manufacturer (Section G) |
NIDEK MEDICAL PRODUCTS, INC. |
3949 valley east industrial dr |
|
birmingham AL 35217 |
|
Manufacturer Contact |
randy
scott
|
3949 valley east industrial dr |
birmingham, AL 35217
|
2058567200
|
|
MDR Report Key | 3786375 |
MDR Text Key | 4441641 |
Report Number | 1039215-2014-00002 |
Device Sequence Number | 1 |
Product Code |
CAW
|
Combination Product (y/n) | N |
Reporter Country Code | TW |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Consumer,Company Representative,Distributor |
Reporter Occupation |
Other
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
02/21/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 905-003NSH |
Device Catalogue Number | 905-003NSH |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/21/2014 |
Initial Date FDA Received | 03/28/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/08/2013 |
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 Age | 81 YR |
|
|