MAUDE report
MAUDE report 58236: PERMANENT PACING LEAD
Injury · received Dec 20, 1996 · OSCOR MEDICAL CORPORATION
Key facts
| MDR report key | 58236 |
|---|---|
| Report number | 1035166-1996-90011 |
| Event type | Injury |
| Brand name | PERMANENT PACING LEAD |
| Model number | PY 52 SBV |
| Catalog number | CELTRA 4444 |
| Manufacturer | OSCOR MEDICAL CORPORATION |
| Product code | DTB |
| Device class | Class III |
| Date received by FDA | Dec 20, 1996 |
| Report date | Sep 11, 1996 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 10–99 MAUDE reports for this brand
- None Death reports for this brand
- 10–99 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: