MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2001-08-23 for MAGNIVISION READING GLASSES * NA manufactured by Magnivision, Inc..
[21616471]
Consumer poked self in the eye with the label called a "hang tag".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045828-2001-00002 |
| MDR Report Key | 349031 |
| Report Source | 00,04 |
| Date Received | 2001-08-23 |
| Date of Report | 2001-08-21 |
| Date of Event | 2001-01-08 |
| Date Facility Aware | 2001-08-13 |
| Report Date | 2001-08-21 |
| Date Mfgr Received | 2001-08-13 |
| Date Added to Maude | 2001-08-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 3700 COMMERCE PARKWAY |
| Manufacturer City | MIRAMAR FL 33025 |
| Manufacturer Country | US |
| Manufacturer Postal | 33025 |
| Manufacturer Phone | 9549869000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGNIVISION READING GLASSES |
| Generic Name | XTRASIGHT +1.75 |
| Product Code | HOI |
| Date Received | 2001-08-23 |
| Model Number | * |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 338348 |
| Manufacturer | MAGNIVISION, INC. |
| Manufacturer Address | 3700 COMMERCE PARKWAY MIRAMAR FL 33025 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-08-23 |