MAUDE report
MAUDE report 8621: POSSIS SUTURELESS MYOCARDIAL LEAD
Injury · received May 2, 1994 · POSSIS MEDICAL, INC.
Key facts
| MDR report key | 8621 |
|---|---|
| Report number | 2124215-1994-00032 |
| Event type | Injury |
| Brand name | POSSIS SUTURELESS MYOCARDIAL LEAD |
| Model number | 4320 |
| Manufacturer | POSSIS MEDICAL, INC. |
| Product code | DTD |
| Device class | Class II |
| Date received by FDA | May 2, 1994 |
| Report date | Apr 14, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 100–999 MAUDE reports for this product code
- 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: