N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 9820140
- MDR report key
- 9820140
- Report number
- 1018233-2020-01751
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-11
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- YONIC ANDERSON
- Address
- 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARDEX? ALL-SILICONE FOLEY CATHETER | FOLEY CATHETER | C.R. BARD, INC. (COVINGTON) -1018233 | EZL | 165816 | 165816 | NGDX1806 | * | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-11 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE FOLEY CATHETER UPON REMOVAL. THE COMPLAINANT REPORTED THAT IT TOOK 9 ATTEMPTS TO REMOVE THE CATHETER AND WHEN THEY FINALLY REMOVED IT, THERE WAS BLEEDING NOTED. THE CATHETER WAS REPORTEDLY OBSERVED TO HAVE 'ROLLED' ON ITSELF IN THE BALLOON AREA UPON REMOVAL. THE COMPLAINANT NOTED THAT THE ASSOCIATES CUT THE TIP OFF THE CATHETER TO BE ABLE TO SHARE WHAT WAS EXPERIENCED. NO MEDICAL INTERVENTION WAS REPORTED. THE ASSOCIATES REPORTEDLY USED ANOTHER CATHETER TO HELP TROUBLESHOOT, AND EXPERIENCED THE SAME ISSUE WITH THE ROLLING.