Brand Name | HEMOPRO2 EXTENSION CABLE |
Type of Device | UNIT, CAUTERY, THERMAL, AC-POWERED |
Manufacturer (Section D) |
MAQUET CV |
45 barbour pond drive |
wayne NJ 07470 |
|
Manufacturer (Section G) |
MAQUET CV |
45 barbour pond drive |
|
wayne NJ 07470 |
|
Manufacturer Contact |
|
45 barbour pond drive |
wayne, NJ 07470
|
|
MDR Report Key | 5521139 |
MDR Text Key | 41306689 |
Report Number | 2242352-2016-00277 |
Device Sequence Number | 1 |
Product Code |
HQO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K101274 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/25/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/23/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | C-VH-4030 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Device Age | YR |
Date Manufacturer Received | 02/25/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 69 YR |
|
|