N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.
MAUDE MDR 9558061
- MDR report key
- 9558061
- Report number
- 1018233-2020-00151
- Event key
- 0
- Event type
- 3
- Date received
- 2020-01-07
- 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 | SL FOLEY SWIVEL 25BX | FOLEY SWIVEL PET | C.R. BARD, INC. (COVINGTON) -1018233 | EYJ | FOL0101 | UNKNOWN | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-07 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE CLIPS CAME OFF EASILY. THE PATIENT STATED HE THOUGHT THE FOLEY HOLDERS WERE OF POOR QUALITY.