Brand Name | BARD URINARY CATHETER TRAYS |
Type of Device | CATHETER, RETENTION TYPE, BALLOON |
Manufacturer (Section D) |
|
MDR Report Key | 12008111 |
MDR Text Key | 256708683 |
Report Number | MW5101901 |
Device Sequence Number | 10 |
Product Code |
EZL
|
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
06/11/2021 |
10 Devices were Involved in the Event: |
1
2
3
4
5
6
7
8
9
10
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 303416A |
Device Catalogue Number | 303416A |
Device Lot Number | NGEX4788 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 06/15/2021 |
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 | 43 YR |
|
|