MAUDE brand profile
MAMMOTOME BIOPSY SYSTEM
MAUDE brand safety profile
Key facts
| Brand name | MAMMOTOME BIOPSY SYSTEM |
|---|
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Unsealed Device Packaging, Device Packaging Compromised, No Patient Involvement, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Failure to Obtain Sample, Device Operates Differently Than Expected, Break Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1