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miraDry MD4000-HPRecalls & reported problems

Miradry, Inc. · Handpiece · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853419006015), received between Apr 18, 2023 and Apr 18, 2023 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Burn(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PT HAD THEIR 2ND TX AND 9 DAYS POST TX THEY DEVELOPED A WOUND. THEY WERE PRESCRIBED ANTIBIOTIC OINTMENT AND TOLD TO KEEP GAUZE ON IT. PICTURES ATTACHED.

    Patient problems: Burn(s)

    MAUDE report 16765774 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.