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 |