MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-16 for ZEON DISCOVERY ZZ-DISCOVERY-TTL manufactured by Kerr Corporation.
[19763552]
A doctor alleged that he had received a shock from a frayed wire on his zeon discovery unit.
Patient Sequence No: 1, Text Type: D, B5
[19825181]
The doctor was shocked by the frayed wire and discontinued use of the device. No medical attention or prescription medication was necessary. To date, the doctor is doing fine. A visual and physical evaluation of the returned device revealed that cuts were present in the outer jacket of the cable. These cuts allowed for the exposure of the internal braided wiring; however, the insulation of the internal braided wiring was intact. It has been determined that the only method of experiencing a shock when touching the braided wire would be if the person touching the wire carried static electricity.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003848022-2014-00005 |
| MDR Report Key | 4094254 |
| Report Source | 05 |
| Date Received | 2014-09-16 |
| Date of Report | 2014-08-19 |
| Date Mfgr Received | 2014-08-19 |
| Date Added to Maude | 2014-09-26 |
| 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 | KERR CORPORATION |
| Manufacturer Street | 3225 DEMING WAY SUITE 190 |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53562 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZEON DISCOVERY |
| Generic Name | SURGICAL HEADLIGHT |
| Product Code | EBA |
| Date Received | 2014-09-16 |
| Catalog Number | ZZ-DISCOVERY-TTL |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 3225 DEMING WAY SUITE 190 MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-16 |