D
Patient 1
A DOCTOR'S OFFICE ALLEGED THAT THE VITALITY SCANNER 2006 HAD SHOCKED A PATIENT DURING A PROCEDURE.
MAUDE MDR 3985166
- MDR report key
- 3985166
- Report number
- 2016150-2014-00435
- Event key
- 0
- Event type
- 3
- Date received
- 2014-08-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MRS. KERRI CASINO
- Address
- 1717 W COLLINS AVE 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 | VITALITY SCANNER 2006 | PULP TESTER | SYBRONENDO | EAT | 973-0234 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-08-06 | 0 | 1. O |
Event Narratives#
N
Patient 1
NO SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. NO MEDICAL ATTENTION OR PRESCRIPTION MEDICATION WAS NECESSARY. NO SYMPTOMS WERE REPORTED BY THE PATIENT. TO DATE, THE PATIENT IS DOING FINE. A VISUAL AND PHYSICAL EVALUATION WAS PERFORMED ON THE RETURNED UNIT. IT WAS DISCOVERED THAT THE BATTERY SNAP WAS DISCONNECTED FROM THE UNIT AND THE WHEEL LABEL WAS COMING OFF.