MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-06 for VITALITY SCANNER 2006 973-0234 manufactured by Sybronendo.
[4754052]
A doctor's office alleged that the vitality scanner 2006 had shocked a patient during a procedure.
Patient Sequence No: 1, Text Type: D, B5
[12218227]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2014-00435 |
| MDR Report Key | 3985166 |
| Report Source | 05 |
| Date Received | 2014-08-06 |
| Date of Report | 2014-07-08 |
| Date Mfgr Received | 2014-07-08 |
| Date Added to Maude | 2014-08-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | SYBRONENDO |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITALITY SCANNER 2006 |
| Generic Name | PULP TESTER |
| Product Code | EAT |
| Date Received | 2014-08-06 |
| Catalog Number | 973-0234 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYBRONENDO |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-06 |