MAUDE report
MAUDE report 11681: INFLATOMATIC 3000 REG-HI
Injury · received Feb 14, 1994 · ZIMMER PATIENT CARE DIVISION
Key facts
| MDR report key | 11681 |
|---|---|
| Report number | 11681 |
| Event type | Injury |
| Brand name | INFLATOMATIC 3000 REG-HI |
| Catalog number | 60-1985-001-00 |
| Manufacturer | ZIMMER PATIENT CARE DIVISION |
| Product code | KCY |
| Device class | Class I |
| PMA or 510(k) number | Device Exempt |
| Date received by FDA | Feb 14, 1994 |
| Report date | Jan 20, 1994 |
| 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
- 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: