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

Model Number NICE1

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

The current information is insufficient to permit a valid conclusion about the cause of this event.A follow-up report will be sent upon completion of the investigation.

Event Description

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.

• Brand Name: NICE RECOVERY SYSTEM
• Type of Device: NICE1
• Manufacturer (Section D): NICE RECOVERY SYSTEM; 2205 central ave; suite a; boulder CO 80301
• Manufacturer (Section G): NICE RECOVERY SYSTEMS; 2205 recovery systems; suite a; boulder CO 80301
• Manufacturer Contact: john mann ; 2205 central ave; suite a; boulder, CO 80301 ; 7202878751
• MDR Report Key: 11701941
• MDR Text Key: 246541797
• Report Number: 3011684767-2021-00003
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• 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: 03/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 26 YR