MAUDE manufacturer profile

SIENTRA, INC. · OUB

MAUDE profile for Instrument For Treatment Of Hyperhidrosis

Key facts

Manufacturer SIENTRA, INC.
Manufacturer group MIRADRY INC.
Product code OUB
Product code name Instrument For Treatment Of Hyperhidrosis

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Swelling, Pain, Unspecified Infection, Abscess, Erythema, Necrosis, Ulceration 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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