MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-12 for ZEON DISCOVERY ZZ-DISCOVERY-FU1 manufactured by Kerr Corporation.
[16055192]
A doctor alleged the battery of the zeon discovery light had slipped out of the discovery holster and contacted a patient's face during a procedure.
Patient Sequence No: 1, Text Type: D, B5
[16282286]
The doctor reported that the clip on the battery pouch had become worn out and was loose when attached to his scrubs; therefore, the battery had slipped out. No injuries were associated with this incident. To date, the patient is doing fine. To date, the product has not been returned; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003848022-2014-00001 |
| MDR Report Key | 3624586 |
| Report Source | 05 |
| Date Received | 2014-02-12 |
| Date of Report | 2014-01-16 |
| Date of Event | 2014-01-16 |
| Date Mfgr Received | 2014-01-16 |
| Date Added to Maude | 2014-05-05 |
| 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 | 2014-02-12 |
| Catalog Number | ZZ-DISCOVERY-FU1 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-02-12 |