MAUDE report
MAUDE report 3320: ACS RX STRREAK.014
Malfunction · received Jul 13, 1992 · ADVANCED CARDIOVASCULAR SYSTEM, INC.
Key facts
| MDR report key | 3320 |
|---|---|
| Report number | 3320 |
| Event type | Malfunction |
| Brand name | ACS RX STRREAK .014 |
| Model number | 2.0 - 20 BALLOON |
| Catalog number | 10621 |
| Manufacturer | ADVANCED CARDIOVASCULAR SYSTEM, INC. |
| Product code | MFB |
| Date received by FDA | Jul 13, 1992 |
| Report date | Jan 23, 1992 |
| Report source | Maude |
At a glance
- None Device problems coded
- 10–99 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: