MAUDE report
MAUDE report 12574: TRACH CARE CUSTOM CLOSED TRACHEAL SUCTION SUSTEM, NEONATAL
No Answer Provided · received Apr 5, 1994 · BALLARD MEDICAL PRODUCTS
Key facts
| MDR report key | 12574 |
|---|---|
| Report number | MW1001465 |
| Event type | No Answer Provided |
| Brand name | TRACH CARE CUSTOM CLOSED TRACHEAL SUCTION SUSTEM, NEONATAL |
| Catalog number | 205 |
| Manufacturer | BALLARD MEDICAL PRODUCTS |
| Product code | BSY |
| Device class | Class I |
| PMA or 510(k) number | Device Exempt |
| Date received by FDA | Apr 5, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 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: