MAUDE manufacturer profile

DJO LLC · KYS

MAUDE profile for Insoles, Medical

Key facts

Manufacturer DJO LLC
Manufacturer group DJO LLC
Product code KYS
Product code name Insoles, Medical

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Patient Device Interaction Problem, Tissue Breakdown, Ulcer, Adverse Event Without Identified Device or Use Problem, Device Misassembled During Manufacturing /Shipping, Pressure Sores, Material Integrity Problem, Patient-Device Incompatibility 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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