MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-13 for REDI-READERS 2514610 NA manufactured by Ni.
[205453]
Customer claims they experienced an allergic reaction to frames.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045828-2000-00001 |
| MDR Report Key | 260356 |
| Date Received | 2000-01-13 |
| Date of Report | 2000-01-12 |
| Date of Event | 1999-11-17 |
| Date Facility Aware | 1999-12-09 |
| Report Date | 2000-01-12 |
| Date Added to Maude | 2000-02-01 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REDI-READERS |
| Generic Name | READING GLASSES +2.75 D |
| Product Code | HQZ |
| Date Received | 2000-01-13 |
| Model Number | 2514610 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | UPC #71815405714 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 252158 |
| Manufacturer | NI |
| Manufacturer Address | NI NI NI * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-01-13 |