MAUDE manufacturer profile
ABBOTT IRELAND · LTJ
MAUDE profile for Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Key facts
| Manufacturer | ABBOTT IRELAND |
|---|---|
| Manufacturer group | ABBOTT IRELAND |
| Product code | LTJ |
| Product code name | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, High Test Results, Low Test Results, No Consequences Or Impact To Patient, Incorrect Measurement, Nonstandard Device, No Code Available Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1