MAUDE report
MAUDE report 52825: PRISM 1000
Death · received Nov 25, 1996 · PICKER INTL, INC.
Key facts
| MDR report key | 52825 |
|---|---|
| Report number | 52825 |
| Event type | Death |
| Brand name | PRISM 1000 |
| Model number | PRISM 1000 |
| Catalog number | UNK |
| Manufacturer | PICKER INTL, INC. |
| Product code | IYX |
| Device class | Class I |
| PMA or 510(k) number | Device Exempt |
| Date received by FDA | Nov 25, 1996 |
| Report date | Nov 22, 1996 |
| Report source | Maude |
At a glance
- None Device problems coded
- 100–999 MAUDE reports for this product code
- 1–9 MAUDE reports for this brand
- 1–9 Death reports for this brand
- 1–9 Injury reports for this brand
- Yes Adverse event flagged
- Yes Product problem flagged
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE medical device reports
MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.
Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date: