N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 9859403
- MDR report key
- 9859403
- Report number
- 1018233-2020-01976
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-20
- Date received
- 2020-03-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- 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? I.C. COMPLETE CARE? URINE METER FOLEY TRAY | COMPONENT (JELLY) | C.R. BARD, INC. (COVINGTON) -1018233 | MJC | 903014A | MYCZ5148 | * | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-20 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE USER FOUND THE JELLY LEAKED UPON OPENING THE PACKAGE. THE DEVICE WAS NOT USED ON THE PATIENT.