N
Patient 1
NO PATIENT INFORMATION WAS PROVIDED IN REGARDS TO ETHNICITY, AND RACE. THE PRODUCT HAS BEEN IDENTIFIED AS A POTENTIAL AFFECTED PRODUCT IN AN ONGOING CLASS II RECALL; THEREFORE NO FURTHER EVALUATION IS NECESSARY.
MAUDE MDR 8197500
- MDR report key
- 8197500
- Report number
- 2016150-2018-00064
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-11-27
- Date received
- 2018-12-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. PAULO CALLE
- Address
- 1717 W COLLINS AVENUE ORANGE CA 92867 US
- Phone
- 714-714-7145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SYBRONENDO | ELEMENTS OBTURATION UNIT | SYBRONENDO | EKZ | 973-0322REP | 91-25387 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-26 | 0 |
Event Narratives#
D
Patient 1
A COMPLAINANT ALLEGED THE UNIT IS OVERHEATING AND ASSISTANT BURNED THEIR FINGER. THE ASSISTANT DID NOT REQUIRE A VISIT TO A PHYSICIAN OFFICE. IT WAS REPORTED THAT THE ASSISTANT HAS FULLY RECOVERED.