MAUDE Adverse Event Report: WHOLE BODY CRYOTHERAPY CHAMBER; BATH, HYDRO-MASSAGE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 09/30/2018

Event Type  malfunction  

Event Description

Reporter states that on (b)(6) 2018 she underwent cryotherapy to treat her stress and anxiety as well as to burn calories.The next day she experienced 2nd degree burns from the right side of her abdomen to her right thigh.She denies any other symptoms.

• Brand Name: WHOLE BODY CRYOTHERAPY CHAMBER
• Type of Device: BATH, HYDRO-MASSAGE
• MDR Report Key: 7973607
• MDR Text Key: 124301969
• Report Number: MW5080617
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 77