MAUDE Adverse Event Report: NICE RECOVERY SYSTEMS NICE RECOVERY SYSTEM; NICE1

Model Number	NICE1
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Necrosis (1971); Tissue Breakdown (2681); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for investigation.However, the device was evaluated by a third-party group.No faults were found and it appears to be functioning properly.The dhr was reviewed and no anomalies or discrepancies were identified that would contribute to the reported event.Should the device be returned for investigation, additional testing will be performed on the wrap a follow-up report will be submitted at that time.No additional containment steps have been implemented at this time.
Event or Problem Description
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.

• Brand Name: NICE RECOVERY SYSTEM
• Common Device Name: NICE1
• Manufacturer (Section D): NICE RECOVERY SYSTEMS; 2205 central ave; suite a; boulder CO 80301
• MDR Report Key: 12029277
• Report Number: 3011684767-2021-00002
• Device Sequence Number: 19897794
• Product Code: ILO
• UDI-Device Identifier: 00862103000307
• UDI-Public: 00862103000307
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: NICE1
• Device Catalogue Number: 40002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other