MAUDE report
MAUDE report 56833: SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE
Injury · received Dec 18, 1996 · MALLINCKRODT MEDICAL, INC.
Key facts
| MDR report key | 56833 |
|---|---|
| Report number | 2029387-1996-00165 |
| Event type | Injury |
| Brand name | SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE |
| Model number | 8 FEN |
| Manufacturer | MALLINCKRODT MEDICAL, INC. |
| Product code | BTO |
| Device class | Class II |
| Date received by FDA | Dec 18, 1996 |
| Report date | Nov 25, 1996 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 100–999 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: