MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-04 for VITALITY SCANNER 2006 973-0234 manufactured by Sybronendo.
[3285368]
A doctor alleged that she had received a high shock while testing the vitality scanner 2006 unit on herself.
Patient Sequence No: 1, Text Type: D, B5
[10375965]
Patient information with regard to age and weight were not provided. It was initially reported by a dealer representative that no injury was associated with this incident. During a follow up phone call on (b)(4) 2013 with the dealer representative, it was reported that the shock the doctor had received was "a surprise", but was not painful at all. Upon further evaluation of the complaint, the dealer representative was contacted a second time on (b)(4) 2013 and the customer's contact information was requested. During a follow up phone call with the doctor's office, it was revealed that the doctor had reported the shock she received as "extremely painful" with pain that had lasted for a few days following. No medical attention or prescription medication was required; the symptoms subsided on their own. To date, the doctor has fully recovered and is doing fine. The device was returned and an evaluation is anticipated, but has not yet begun.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2013-00001 |
| MDR Report Key | 2942428 |
| Report Source | 05 |
| Date Received | 2013-02-04 |
| Date of Report | 2013-01-03 |
| Date Mfgr Received | 2013-01-03 |
| Date Added to Maude | 2013-04-18 |
| 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. WENDY GARMAN |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| 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 | 2013-02-04 |
| Catalog Number | 973-0234 |
| Lot Number | 26-42577 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-02-04 |