Brand Name | BARD SILICONE FOLEY CATHETER |
Type of Device | CATHETER, RETENTION TYPE, BALLOON |
Manufacturer (Section D) |
|
MDR Report Key | 7709858 |
MDR Text Key | 114851258 |
Report Number | MW5078505 |
Device Sequence Number | 2 |
Product Code |
EZL
|
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 |
07/18/2018 |
3 Devices were Involved in the Event: |
1
2
3
|
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 | A897516 |
Device Catalogue Number | A897516 |
Device Lot Number | NGBY1010 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 07/20/2018 |
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|