Instrument For Treatment Of Hyperhidrosis
FDA adverse event reports and recall history for instrument for treatment of hyperhidrosis (product code OUB), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 655
- Deaths
- 2
- Injuries
- 640
- Malfunctions
- 12
Reports per year
Source: FDA adverse event reports by year received, 2013–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2015-11-06TerminatedLabeling design
miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.
Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters.
- 2011-06-17TerminatedDevice Design
MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the miraDry biotip and the miraDry Treatment Template system. Miramar Labs, Inc. 445 Indio Way Sunnyvale, CA 94085 Intended use: Treatment of primary axillary hyperhidrosis.
Reports of skin burns on axilla after treatment with the miraDry System.
Monitor instrument for treatment of hyperhidrosis automatically
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