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

Model Number NICE1

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cellulitis (1768); Pain (1994); Inadequate Pain Relief (2388); Skin Burning Sensation (4540); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for investigation.The dhr was reviewed and no anomalies or discrepancies were identified that would contribute to the reported event.Current information is insufficient to permit a valid conclusion about the cause of this event.Should the device be returned for investigation, a follow-up report will be submitted at that time.No additional containment steps have been implemented at this time.Additional information was obtained that on 11/2019 during a courtesy call by the distributor indicating the patient was fine and there were no issues.This contradicts the information that was provided on 12/21/2020.

Event Description

It was reported that a patient was admitted to the ed after 3 weeks of intermittent treatment with the nice1 recovery system.The nice1 recovery system was initially applied status post bunionectomy surgery, when the patient reported experiencing a burning/freezing pain.The treatment did not include compression.The patient used the device for 2 weeks and stopped, per surgeon's request at a 2 week post-op follow-up, after reporting no relief to the severe swelling and continued pain to the surgical site.The patient resumed treatment with the device, 3 weeks after the initial surgery, in an attempt to relive the reported increased swelling to the surgical site.The patient reported their whole body was cold during the resumed treatment.The patient was reported to be hospitalized for 1 week, was administered iv antibiotics and was treated for cellulitis, complex regional pain.The patient is reported to be improving but not fully recovered with continuing wound issues on the second and third toes.No further patient information has been provided.

• 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: 12112545
• MDR Text Key: 266179940
• Report Number: 3011684767-2021-00001
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00862103000387
• UDI-Public: (01)00862103000387(11)200915
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• 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
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other