MAUDE manufacturer profile
SPATZ FGIA INC. · LTI
MAUDE profile for Implant, Intragastric For Morbid Obesity
Key facts
| Manufacturer | SPATZ FGIA INC. |
|---|---|
| Manufacturer group | SPATZ FGIA INC. |
| Product code | LTI |
| Product code name | Implant, Intragastric For Morbid Obesity |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Deflation Problem, No Clinical Signs, Symptoms or Conditions, Abdominal Pain, Patient-Device Incompatibility, Air/Gas in Device, Vomiting, Insufficient Information, Migration or Expulsion of Device 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