MAUDE manufacturer profile

ZELTIQ AESTHETICS, INC. · OOK

MAUDE profile for Dermal Cooling Pack/Vacuum/Massager

Key facts

Manufacturer ZELTIQ AESTHETICS, INC.
Manufacturer group ZELTIQ AESTHETICS, INC.
Product code OOK
Product code name Dermal Cooling Pack/Vacuum/Massager

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Hyperplasia, Insufficient Information, Hernia, Patient-Device Incompatibility, Pain, Deformity/ Disfigurement, Therapeutic or Diagnostic Output Failure 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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