MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2007-05-16 for DIMENSION-3 DENTAL LOUPES DMT2L-L-01MDSL-OR manufactured by Kerr Corporation.
[636464]
In 2007, the pt informed kerr corp that he began experiencing headaches and neck aches due to overcompensating for incorrect loupe measurements of the dimension-3 dental loupes that he was originally prescribed in five years earlier.
Patient Sequence No: 1, Text Type: D, B5
[7961394]
The device was repaired and then returned to the pt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003848022-2007-00001 |
| MDR Report Key | 850866 |
| Report Source | 04,05 |
| Date Received | 2007-05-16 |
| Date of Report | 2007-02-26 |
| Date of Event | 2007-02-01 |
| Date Mfgr Received | 2007-02-26 |
| Date Added to Maude | 2007-05-18 |
| 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 | WENDY URTEL |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| 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 | DIMENSION-3 DENTAL LOUPES |
| Generic Name | LOUPE, DIAGNOSTIC/SURGICAL |
| Product Code | FSP |
| Date Received | 2007-05-16 |
| Catalog Number | DMT2L-L-01MDSL-OR |
| Lot Number | T47254 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 838116 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 3225 DEMING WAY SUITE 190 MIDDLETON WI 53562 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-16 |