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

Model Number NICE1

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Necrosis (1971); Tissue Breakdown (2681); Swelling/ Edema (4577)

Event Type  Injury  

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 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
• Type of Device: NICE1
• Manufacturer (Section D): NICE RECOVERY SYSTEMS; 2205 central ave; suite a; boulder CO 80301
• Manufacturer (Section G): NICE RECOVERY SYSTEMS; 2205 central ave; suite a; boulder CO 80301
• Manufacturer Contact: john mann ; 2205 central ave; suite a; boulder, CO 80301 ; 7202878751
• MDR Report Key: 12029277
• MDR Text Key: 257145451
• Report Number: 3011684767-2021-00002
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00862103000307
• UDI-Public: 00862103000307
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NICE1
• Device Catalogue Number: 40002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other