MAUDE manufacturer profile
ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH · HEB
MAUDE profile for Tampon, Menstrual, Unscented
Key facts
| Manufacturer | ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH |
|---|---|
| Manufacturer group | ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH |
| Product code | HEB |
| Product code name | Tampon, Menstrual, Unscented |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Misassembled, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Foreign Body In Patient, Material Separation, No Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, Device Contaminated During Manufacture or Shipping 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