MAUDE report
MAUDE report 70140: APR HOODED ENHANCED INSERT 28MM/57MM
Malfunction · received Feb 19, 1997 · SULZER ORTHOPEDICS, INC.
Key facts
| MDR report key | 70140 |
|---|---|
| Report number | 2935620-1997-00006 |
| Event type | Malfunction |
| Brand name | APR HOODED ENHANCED INSERT 28MM/57MM |
| Catalog number | 4338-28-057 |
| Manufacturer | SULZER ORTHOPEDICS, INC. |
| Product code | KWB |
| Device class | Class III |
| Date received by FDA | Feb 19, 1997 |
| Report date | Feb 18, 1997 |
| 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
- None Injury reports for this brand
- 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: