CHATTANOOGA 2176KITRecalls & reported problems
Djo, LLC · INTELECT RPW 2 120V, USA KIT · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00190446673170), received between Dec 8, 2025 and Dec 8, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Temperature Problem” (1 report).
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
- Temperature 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.
InjuryDec 8, 2025Temperature Problem; Temperature Problem
CUSTOMER REPORTS INJURY TO CUSTOMER, CUSTOMER REPORTED FRICTION TYPE BURNS ON HER RIGHT-SIDE MID BACK DAYS AFTER TREATMENT WITH RPW2 2176KIT SN (B)(6). CUSTOMER REPORTS NO ANOMALIES WITH UNIT, NO MEDICAL TREATMENT RENDERED.
Patient problems: Burn(s)
MAUDE report 23737952 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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