MAUDE manufacturer profile
SIEMENS HEALTHCARE DIAGNOSTICS, INC. · LTJ
MAUDE profile for Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Key facts
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
|---|---|
| Manufacturer group | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Product code | LTJ |
| Product code name | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Mechanical Problem, Adverse Event Without Identified Device or Use Problem, Low Test Results, High Test Results, No Clinical Signs, Symptoms or Conditions, Human Factors Issue, No Consequences Or Impact To Patient 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