MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-07-07 for REDI-READERS RR 5214 4037925 manufactured by Magnivision.
[16301042]
Consumer poked themself in the eye with the hang tag while trying on reading glasses at store.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045828-2004-00002 |
| MDR Report Key | 610079 |
| Report Source | 04 |
| Date Received | 2004-07-07 |
| Date of Report | 2004-07-01 |
| Date of Event | 2004-06-12 |
| Date Facility Aware | 2004-06-29 |
| Report Date | 2004-07-01 |
| Date Reported to FDA | 2004-07-07 |
| Date Added to Maude | 2005-06-06 |
| 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 | 9549863284 |
| 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 5214 |
| Product Code | HOI |
| Date Received | 2004-07-07 |
| Model Number | RR 5214 |
| Catalog Number | 4037925 |
| 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 | 599885 |
| Manufacturer | MAGNIVISION |
| Manufacturer Address | 3700 COMMERCE PKWY. MIRAMAR FL 33025 US |
| Baseline Brand Name | REDI-READERS |
| Baseline Generic Name | 5200 SERIES 5214 |
| Baseline Model No | RR 5214 |
| Baseline Catalog No | 4037925 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-07-07 |