Brand Name | C-VIEW 20X30CM |
Type of Device | C-VIEW |
Manufacturer (Section D) |
ASPEN SURGICAL PRODUCTS, CALEDONIA |
6945 southbelt dr. s.e. |
caledonia MI 49316 |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
megan
morrissey
|
6945 southbelt dr. s.e. |
caledonia, MI 49316
|
|
MDR Report Key | 6832236 |
MDR Text Key | 84366097 |
Report Number | 1836161-2017-00082 |
Device Sequence Number | 1 |
Product Code |
NAD
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/30/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/30/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/01/2020 |
Device Model Number | 2258 |
Device Lot Number | 125803 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 08/01/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|