MAUDE report
MAUDE report 83966: IMX PSA REAGENT
Malfunction · received Apr 9, 1997 · ABBOTT HEALTH PRODUCTS, INC.
Key facts
| MDR report key | 83966 |
|---|---|
| Report number | 2623532-1997-00010 |
| Event type | Malfunction |
| Brand name | IMX PSA REAGENT |
| Catalog number | 2245-20 |
| Manufacturer | ABBOTT HEALTH PRODUCTS, INC. |
| Product code | LTJ |
| Device class | Class II |
| Date received by FDA | Apr 9, 1997 |
| Report date | Apr 8, 1997 |
| Report source | Maude |
At a glance
- None Device problems coded
- 100–999 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: