Brand Name | LUBRI-SIL I.C. COMPLETE CARE FOLEY CATHETER TRAY |
Type of Device | CATHETER, RETENTION TYPE, BALLOON |
Manufacturer (Section D) |
BARD MEDICAL / C. R. BARD, INC. |
covington GA 30014 |
|
MDR Report Key | 12049804 |
MDR Text Key | 258167259 |
Report Number | MW5102035 |
Device Sequence Number | 1 |
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 |
06/18/2021 |
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 |
Health Professional
|
Device Expiration Date | 01/31/2023 |
Device Model Number | 303416A |
Device Catalogue Number | 303416A |
Device Lot Number | NGEX4788 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 06/22/2021 |
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 | 84 YR |
|
|