N
Patient 1
PRODUCT NOT RETURNED FOR EVALUATION.
MAUDE MDR 6604514
- MDR report key
- 6604514
- Report number
- 1941138-2017-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-05-16
- Date received
- 2017-06-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. JOSE ESPINO
- Address
- 13705 SHORELINE COURT EAST EARTH CITY MO 63045 US
- Phone
- 314-314-3143
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DURAFLOR HALO 5% VARNISH | VARNISH | MEDICAL PRODUCTS LABORATORIES, INC. | LBH | 1030-WB32 | 1030-WB32 | 53156 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-06-01 | 0 | 1. O |
Event Narratives#
D
Patient 1
A CHILD HAD A DURAFLOR HALO TREATMENT. LATER THAT DAY THE CHILD EXPERIENCED DIARRHEA AND HEADACHES. PARENT ADMINISTERED TYLENOL. THIS WAS THE FIRST TIME THAT THE PATIENT IN QUESTION USED THIS PRODUCT. THE PATIENT IS ALLERGIC TO SOY, SHE IS DAIRY INTOLERANT, AND HAS COELIAC.