MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-15 for ZEON APOLLO ZZ-APOLLO-TTL manufactured by Kerr Corporation.
[4419281]
A complainant alleged that the zeon apollo device had shocked her during use.
Patient Sequence No: 1, Text Type: D, B5
[11721281]
No injuries were associated with this incident; the complainant is doing fine. To date, the product has not been returned; therefore, no evaluation can be conducted. This incident is mdr reportable as a malfunction because the device could cause or contribute to a serious injury if the malfunction were to recur.
Patient Sequence No: 1, Text Type: N, H10
[26416186]
A visual and physical evaluation of the returned device revealed that there was a cut in the outer jacket of the cable exposing the braided copper wire which is not electrically connected to anything and is not a source of delivery shock. An inspection of the battery pack revealed that it functions as expected. These investigation results indicate that the incident which had occurred was not due to a product failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003848022-2014-00003 |
| MDR Report Key | 3752030 |
| Report Source | 05 |
| Date Received | 2014-04-15 |
| Date of Report | 2014-03-19 |
| Date Mfgr Received | 2014-03-19 |
| Date Added to Maude | 2014-06-06 |
| 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 | DENTAL ASSISTANT |
| 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 APOLLO |
| Generic Name | SURGICAL HEADLIGHT |
| Product Code | EBA |
| Date Received | 2014-04-15 |
| Catalog Number | ZZ-APOLLO-TTL |
| Operator | DENTAL ASSISTANT |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2014-04-15 |