KOLD WHOLE BODY CRYOTHERAPY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-17 for KOLD WHOLE BODY CRYOTHERAPY manufactured by .

Event Text Entries

[97796334] 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)
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5074673
• MDR Report Key: 7203020
• Date Received: 2018-01-17
• Date of Report: 2018-01-03
• Date of Event: 2017-12-23
• Date Added to Maude: 2018-01-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: KOLD WHOLE BODY CRYOTHERAPY
• Generic Name: IMMERSION HYDROBATH
• Product Code: ILJ
• Date Received: 2018-01-17
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-01-17