MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-19 for REXYLLIUM 5 manufactured by Jeneric/pentron, Inc..
[151417]
Rptr has been diagnosed with polycythemia vera and is questioning whether this condition may have been caused by repeated exposure to beryllium particulates in the air over the past 30 years. The rptr is very active in the dental association and is mainly concerned that there may be a safer alloy available. The rptr finds no fault with the mfr, but feels more studies are needed on the possibility of contracting berylliosis from this type of exposure to beryllium.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018948 |
| MDR Report Key | 278786 |
| Date Received | 2000-05-19 |
| Date of Report | 2000-05-19 |
| Date of Event | 2000-02-01 |
| Date Added to Maude | 2000-05-24 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REXYLLIUM 5 |
| Generic Name | DENTAL ALLOY WITH 2% BERYLLIUM |
| Product Code | EJT |
| Date Received | 2000-05-19 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 269800 |
| Manufacturer | JENERIC/PENTRON, INC. |
| Manufacturer Address | 53 N. PLAINS INDUSTRIAL RD. PO BOX 724 WALLINGFORD CT 064920724 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-05-19 |