Transform (T3 Applicator) AG609899ARecalls & reported problems
Inmode M.D Ltd · Transform (T3 Applicator) · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290016633689), received between Jun 30, 2024 and Jun 22, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem2
- Insufficient Device Problem Information1
Patient problems
- Full thickness (Third Degree) Burn2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 22, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
FULL THICKNESS BURN ON ABDOMEN POST TRANSFORM TREATMENT.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 22304429 ↗InjuryJun 30, 2024Use of Device Problem; Use of Device Problem
THIRD DEGREE BURNS ON ABDOMEN POST TRANSFORM TREATMENT.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 19640811 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.