D
Patient 1
(B)(4).
MAUDE MDR 4805594
- MDR report key
- 4805594
- Report number
- 1521608-2015-00002
- Event key
- 0
- Event type
- 3
- Date received
- 2015-05-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Address
- 23700 MERCANTILE RD BEACHWOOD OH 44122 US
- Phone
- 216-216-2168
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HOUVA 4 | PHOTOTHERAPY UNIT | NATIONAL BIOLOGICAL CORP. | KGL | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-05-28 | 0 |
Event Narratives#
N
Patient 1
DURING DISCUSSION WITH (B)(6) CLINICIANS, IT WAS FOUND THAT THE FACILITY WAS NOT FOLLOWING NBC'S RECOMMENDED / PUBLISHED PROTOCOL (KOO). THE FACILITY WAS ADVISED TO UTILIZE ONLY NBC RECOMMENDED AND PUBLISHED PROTOCOLS, AS OUTLINED IN THE IFU, FOR SAFE AND EFFECTIVE TREATMENT. THE FACILITY WAS FOLLOWING ALL OTHER NBC GUIDELINES.