MAUDE manufacturer profile

GIVEN IMAGING LTD., YOQNEAM · NEZ

MAUDE profile for System, Imaging, Gastrointestinal, Wireless, Capsule

Key facts

Manufacturer GIVEN IMAGING LTD., YOQNEAM
Manufacturer group GIVEN IMAGING LTD., YOQNEAM
Product code NEZ
Product code name System, Imaging, Gastrointestinal, Wireless, Capsule

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Entrapment of Device, Foreign Body In Patient, Radiation Exposure, Unintended, No Consequences Or Impact To Patient, Abdominal Pain, Adverse Event Without Identified Device or Use Problem, Unintended Radiation Exposure, No Clinical Signs, Symptoms or Conditions 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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