MAUDE Adverse Event Report: KOLD WHOLE BODY CRYOTHERAPY; IMMERSION HYDROBATH

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Burning Sensation (2146); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 12/23/2017

Event Type  Injury  

Event Description

On saturday (b)(6) 2017, i for the first time underwent whole body cryotherapy at the commercial entity kold cryotherapy and floatation located on (b)(6).My son accompanied me to this as he was a frequent visitor of this site.I underwent approx 3 mins of whole body cryotherapy.My son who had the same therapy before me had no adverse effects.After i exited the therapy, i had whole body redness and excessive burning behind my left knee.Several hours later, i developed first degree and some area of second degree cold burns with blister formation.With wound care, this is now resolving and healing.Mfr address - kold cryotherapy and floatation, (b)(6), united states.Mfr website (b)(4).Explanation: i contacted the business to inform them of the burn and recommended they check equipment.I don't plan to pursue legal action.Product type: comfort and relaxation.Document number: (b)(4).Report number: (b)(4).

• Brand Name: KOLD WHOLE BODY CRYOTHERAPY
• Type of Device: IMMERSION HYDROBATH
• MDR Report Key: 7203020
• MDR Text Key: 97796334
• Report Number: MW5074673
• 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: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR