MAUDE manufacturer profile

KARL STORZ SE & CO. KG · HFA

MAUDE profile for Amnioscope, Transabdominal (Fetoscope) (And Accessories)

Key facts

Manufacturer KARL STORZ SE & CO. KG
Manufacturer group KARL STORZ SE & CO. KG
Product code HFA
Product code name Amnioscope, Transabdominal (Fetoscope) (And Accessories)

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 1–9 Injury reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Reduced Blood Flow, Adverse Event Without Identified Device or Use Problem, Hemorrhage/Blood Loss/Bleeding, Failure to Anastomose, Incompetent Cervix, Abdominal Cramps, Hematoma, High Blood Pressure/ Hypertension 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

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