Brand Name | CODMAN 6FR MPD ENVOY |
Type of Device | CATHETER, PERCUTANEOUS |
Manufacturer (Section D) |
CODMAN & SHURTLEFF, INC. |
ranham MA 02767 |
|
MDR Report Key | 9834752 |
MDR Text Key | 183740940 |
Report Number | MW5093750 |
Device Sequence Number | 1 |
Product Code |
DQY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/11/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/13/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/30/2020 |
Device Model Number | 670-258-90 |
Device Catalogue Number | 670-258-90 |
Device Lot Number | 30337919 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 41 YR |
Patient Weight | 86 |
|
|