MAUDE report
MAUDE report 8615: SEABROOK UNIT/PAD
Injury · received Mar 9, 1994 · SEABROOK MEDICAL SYSTEMS
Key facts
| MDR report key | 8615 |
|---|---|
| Report number | 36869-1994-00001 |
| Event type | Injury |
| Brand name | SEABROOK UNIT/PAD |
| Catalog number | SMS 2000 |
| Manufacturer | SEABROOK MEDICAL SYSTEMS |
| Product code | IRQ |
| Device class | Class I |
| PMA or 510(k) number | Device Exempt |
| Date received by FDA | Mar 9, 1994 |
| Report date | Feb 21, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 10–99 MAUDE reports for this product code
- 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: