MAUDE manufacturer profile

RESHAPE LIFESCIENCES · LTI

MAUDE profile for Implant, Intragastric For Morbid Obesity

Key facts

Manufacturer RESHAPE LIFESCIENCES
Manufacturer group RESHAPE LIFESCIENCES
Product code LTI
Product code name Implant, Intragastric For Morbid Obesity

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Insufficient Information, Vomiting, Device Slipped, Erosion, Adverse Event Without Identified Device or Use Problem, Pain, Fluid/Blood Leak 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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