MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-12-18 for HIRES PLUS EMT3H-C-01MDSL-OR manufactured by Kerr Corporation.
[3242195]
A doctor alleged that after wearing his hires loupe sideways during a three (3) hour patient procedure, he experienced eye ulcers and a burn on his right eye. The doctor alleged that he had noticed that the focal point for the device was not correct; however, he continued to use the device by turning it sideways.
Patient Sequence No: 1, Text Type: D, B5
[10483617]
The doctor sought medical attention from an optometrist and was diagnosed with a burned eye. An antibiotic eye drop and a steroid eye drop (pred forte) were prescribed; however, the name of the antibiotic eye drop was not provided. It was confirmed by the doctor that his right eye is now feeling better; however, his vision in that eye is still adjusting. The device was returned and evaluated, yielding results within specifications.
Patient Sequence No: 1, Text Type: N, H10
[16929572]
A dhr review revealed that there were no deviations from the manufacturing process and that the device was released within product specifications. These investigation results indicate that this incident is an isolated incident which occurred as a result of a user/technique related issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003848022-2012-00006 |
| MDR Report Key | 2878406 |
| Report Source | 05 |
| Date Received | 2012-12-18 |
| Date of Report | 2012-11-19 |
| Date Mfgr Received | 2012-11-19 |
| Date Added to Maude | 2012-12-19 |
| 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 | 7145167602 |
| 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 | HIRES PLUS |
| Generic Name | SURGICAL LOUPE |
| Product Code | FSP |
| Date Received | 2012-12-18 |
| Catalog Number | EMT3H-C-01MDSL-OR |
| Operator | DENTIST |
| 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; 2. Required No Informationntervention | 2012-12-18 |