MAUDE report
MAUDE report 70305: IVORY RUBBER DAM CLAMP W8A
Malfunction · received Feb 14, 1997 · HARAEUS KULZER, INC. DENTAL PRODUCTS DIV.
Key facts
| MDR report key | 70305 |
|---|---|
| Report number | 1925223-1997-00018 |
| Event type | Malfunction |
| Brand name | IVORY RUBBER DAM CLAMP W8A |
| Model number | * |
| Catalog number | 57536 |
| Manufacturer | HARAEUS KULZER, INC. DENTAL PRODUCTS DIV. |
| Product code | EEF |
| Device class | Class I |
| PMA or 510(k) number | Device Exempt |
| Date received by FDA | Feb 14, 1997 |
| Report date | Feb 10, 1997 |
| 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: