MAUDE manufacturer profile
GRACE MEDICAL, INC. · ETB
MAUDE profile for Prosthesis, Partial Ossicular Replacement
Key facts
| Manufacturer | GRACE MEDICAL, INC. |
|---|---|
| Manufacturer group | GRACE MEDICAL, INC. |
| Product code | ETB |
| Product code name | Prosthesis, Partial Ossicular Replacement |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Shipping Damage or Problem, Material Twisted/Bent, Break, Facial Nerve Paralysis, Skin Tears, Device Operates Differently Than Expected 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