MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-08-29 for HIRES ELLIPTIC HE1T2L-S-02MDSL-OR manufactured by Metrex Research, Llc.
[3703761]
A doctor alleged that he had developed an allergic reaction in the form of redness and swelling around the eyes after wearing the hires elliptic dental loupe. The doctor reported that over the years of use, the paint layer had worn away from the frames of the hires elliptic loupe; therefore, the metal of the frames was contacting his skin directly. The doctor reported that he had begun reacting to the frames when the paint layer had worn away.
Patient Sequence No: 1, Text Type: D, B5
[11237454]
The doctor used a prescription cortisone ointment for treatment of the symptoms. The symptoms subsided after approximately one (1) week. To date, the doctor has fully recovered and is doing fine. A visual and physical evaluation performed on the actual device revealed that the paint had worn away from the frames.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003848022-2013-00009 |
| MDR Report Key | 3316819 |
| Report Source | 05,08 |
| Date Received | 2013-08-29 |
| Date of Report | 2013-08-19 |
| Date Mfgr Received | 2013-08-19 |
| Date Added to Maude | 2013-08-29 |
| 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 | HIRES ELLIPTIC |
| Generic Name | SURGICAL LOUPE |
| Product Code | FSP |
| Date Received | 2013-08-29 |
| Catalog Number | HE1T2L-S-02MDSL-OR |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METREX RESEARCH, LLC |
| 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 | 2013-08-29 |