MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-30 for DIMENSION 3 LOUPES DMT2L-X-RPZFME-OR manufactured by Kerr Corporation.
[4620794]
A complainant alleged that the paint of the dimension 3 loupes was chipping off causing her to get an eye infection.
Patient Sequence No: 1, Text Type: D, B5
[11807056]
The complainant used a steroidal anti-inflammatory eye drops and had to rest her eye for treatment. Multiple attempts were made to contact the complainant to obtain further information; however, the complainant is on vacation. An update will be provided if any new information is received. A device evaluation is anticipated but has not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[25891071]
During a follow-up phone call with the complainant on 06/05/14, it was confirmed that to date, her eye is feeling better. A visual evaluation of the returned device confirmed the presence of paint flakes on the carrier lenses of the device. The location of the paint deterioration/flaking on the rear bridge of the device indicates that the complainant wears the loupes with the bridge pressed up against her forehead. It is possible that the natural acids of the wearer's skin may have broken down the paint on the frame causing it to flake off due to prolonged contact of the frame to the wearer's skin. 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 | 3003848022-2014-00004 |
| MDR Report Key | 3841030 |
| Report Source | 05 |
| Date Received | 2014-05-30 |
| Date of Report | 2014-05-06 |
| Date Mfgr Received | 2014-05-06 |
| Date Added to Maude | 2014-05-30 |
| 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 HYGIENIST |
| 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 | DIMENSION 3 LOUPES |
| Generic Name | LOUPE, DIAGNOSIC/SURGICAL |
| Product Code | FSP |
| Date Received | 2014-05-30 |
| Catalog Number | DMT2L-X-RPZFME-OR |
| 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; 2. Required No Informationntervention | 2014-05-30 |