MAUDE manufacturer profile
BARDY DIAGNOSTICS, INC. · DSH
MAUDE profile for Recorder, Magnetic Tape, Medical
Key facts
| Manufacturer | BARDY DIAGNOSTICS, INC. |
|---|---|
| Manufacturer group | QUALITEL CORPORATION |
| Product code | DSH |
| Product code name | Recorder, Magnetic Tape, Medical |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Skin Inflammation/ Irritation, Contact Dermatitis, Insufficient Information, Product Quality Problem, Skin Discoloration, Use of Device Problem, Patient-Device Incompatibility 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