NICE NICE1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00862103000307), received between Apr 21, 2021 and Jun 18, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WAS HOSPITALIZED FOR 4 WEEKS AND DIAGNOSED WITH COMPARTMENT SYNDROME INDUCED BY CRYOTHERAPY AFTER USING THE DEVICE STATUS POST BUNIONECTOMY AND FIRST METATARSAL OSTEOTOMY. THE WRAP WAS BUILT INTO THE SURGICAL DRESSING AFTER PUTTING LAYERS OF WEB ROLL ON THE SKIN AND COMPRESSION WAS NOT USED. THE PATIENT UNDERWENT HYPERBARIC OXYGEN TREATMENT WHILE HE WAS HOSPITALIZED BUT NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Necrosis; Swelling/ Edema; Tissue Breakdown

  MAUDE report 12029277 ↗
• InjuryApr 21, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAS A FROST-BITE TYPE INJURY AFTER USING THE DEVICE POSTOPERATIVELY. THE PATIENT WAS REPORTED TO BE SLIGHTLY IMPROVING AND WAS DISCHARGED FROM THE HOSPITAL WITH PENDING SKIN GRAFT OR DELAYED PRIMARY CLOSURE. NO FURTHER EVENT INFORMATION IS AVAILABLE.

  Patient problems: Tissue Breakdown

  MAUDE report 11701941 ↗