MAUDE report
MAUDE report 61012: PALMAZ-SCHATZ BALLOON EXPLANDABLE STENT WITH DELIVERY SYSTEM
Injury · received Dec 30, 1996 · NEW HERSEY PLANT
Key facts
| MDR report key | 61012 |
|---|---|
| Report number | 2247023-1996-00156 |
| Event type | Injury |
| Brand name | PALMAZ-SCHATZ BALLOON EXPLANDABLE STENT WITH DELIVERY SYSTEM |
| Catalog number | PS1540 |
| Manufacturer | NEW HERSEY PLANT |
| Product code | MAF |
| Device class | Class III |
| Date received by FDA | Dec 30, 1996 |
| Report date | Dec 3, 1996 |
| 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: