Brand Name | BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER |
Type of Device | FOLEY CATHETER (SILICONE) |
Manufacturer (Section D) |
C.R. BARD, INC. (COVINGTON) -1018233 |
8195 industrial blvd |
covington GA 30014 |
|
Manufacturer (Section G) |
C.R. BARD, INC. (COVINGTON) -1018233 |
8195 industrial blvd |
|
covington GA 30014 |
|
Manufacturer Contact |
yonic
anderson
|
8195 industrial blvd |
covington, GA 30014
|
7707846100
|
|
MDR Report Key | 9596876 |
MDR Text Key | 180402144 |
Report Number | 1018233-2020-00373 |
Device Sequence Number | 1 |
Product Code |
EZL
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K040504 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/16/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/16/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 1758SI16 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/27/2019 |
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 |