MAUDE report
MAUDE report 30339: ALPHA PALTE DIALYZER
Malfunction · received Feb 20, 1996 · COBE LABORATORIES, INC.
Key facts
| MDR report key | 30339 |
|---|---|
| Report number | MW1008384 |
| Event type | Malfunction |
| Brand name | ALPHA PALTE DIALYZER |
| Model number | ALPHA A700 |
| Catalog number | N0184 9004 |
| Manufacturer | COBE LABORATORIES, INC. |
| Product code | FWZ |
| Device class | Class I |
| PMA or 510(k) number | Device Exempt |
| Date received by FDA | Feb 20, 1996 |
| Report date | Feb 7, 1996 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 1–9 MAUDE reports for this brand
- None Death reports for this brand
- None Injury reports for this brand
- No 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: