MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-14 for REDI-READERS RR 5212 * manufactured by Magnivision, Inc..
[397273]
Customer claimed to have a burning sensation and rash near nose pads when wearing a new pair of company's glasses. They normally wear company's glasses with no problems including this same style.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045828-2004-00001 |
| MDR Report Key | 597763 |
| Date Received | 2004-06-14 |
| Date of Report | 2004-05-26 |
| Date of Event | 2004-05-13 |
| Date Facility Aware | 2004-05-25 |
| Report Date | 2004-05-26 |
| Date Added to Maude | 2005-05-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 3700 COMMERCE |
| Manufacturer City | MIRAMAR FL 33025 |
| Manufacturer Country | US |
| Manufacturer Postal | 33025 |
| Manufacturer Phone | * |
| Manufacturer G1 | MAGNIVISION |
| Manufacturer Street | 3700 COMMERCE |
| Manufacturer City | MIRAMAR FL 33025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33025 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REDI-READERS |
| Generic Name | 5200 SERIES |
| Product Code | HOI |
| Date Received | 2004-06-14 |
| Model Number | RR 5212 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | * |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 587596 |
| Manufacturer | MAGNIVISION, INC. |
| Manufacturer Address | 3700 COMMERCE PKWY. MIRAMAR FL 33025 US |
| Baseline Brand Name | REDI-READERS |
| Baseline Generic Name | 5200 SERIES |
| Baseline Model No | RR 5212 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-06-14 |