MAUDE report
MAUDE report 43436: PEMT 5 BALLOON DILATATION CATHETER
Injury · received Oct 17, 1996 · MEDI-TECH A DIV OF BOSTON SCIENTIFIC, CORP
Key facts
| MDR report key | 43436 |
|---|---|
| Report number | 1219544-1996-00089 |
| Event type | Injury |
| Brand name | PEMT 5 BALLOON DILATATION CATHETER |
| Catalog number | 10-972 |
| Manufacturer | MEDI-TECH A DIV OF BOSTON SCIENTIFIC, CORP |
| Product code | LIT |
| Device class | Class II |
| Date received by FDA | Oct 17, 1996 |
| Report date | Sep 19, 1996 |
| Report source | Maude |
At a glance
- None Device problems coded
- Yes 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: