MAUDE report
MAUDE report 4976: PASZ PULSATILE ANTI EMBOLISM SYSTEM
Injury · received Jun 11, 1993 · BAXTER HEALTHCARE CORPORATIOLN - PHARMASEAL DIVISION
Key facts
| MDR report key | 4976 |
|---|---|
| Report number | 4976 |
| Event type | Injury |
| Brand name | PASZ PULSATILE ANTI EMBOLISM SYSTEM |
| Model number | 35E10000 AND 35E0000 AIR PUMP |
| Catalog number | SAME AS MODEL NUMBER |
| Manufacturer | BAXTER HEALTHCARE CORPORATIOLN - PHARMASEAL DIVISION |
| Product code | CBA |
| Device class | Class II |
| Date received by FDA | Jun 11, 1993 |
| Report date | Apr 28, 1993 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1–9 MAUDE reports for this product code
- 1–9 MAUDE reports for this brand
- None Death reports for this brand
- 1–9 Injury reports for this brand
- Yes Adverse event flagged
- No 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: