• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WHOLE BODY CRYOTHERAPY; BATH, HYDRO-MASSAGE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Skin Irritation (2076); Skin Inflammation (2443)
Event Date 09/18/2017
Event Type  Injury  
Event Description
A (b)(6) man presented for the evaluation of a diffuse papular eruption.Over the preceding two weeks, he had received eight whole body cryotherapy treatments in a cold chamber after exercise.During treatments, his face, hands and feet were covered; he stood with his arms at his sides, thus also sparing the axillae from exposure.The eruption started on the lower extremities and proceeded to involve the trunk and upper extremities over the following days.He had occasional mild pruritus, and mild tenderness of the abdominal lesions.The pt had no systemic symptoms associated with the skin eruption.Physical examination revealed numerous erythematous, edematous pink papules, some coalescing into plaques, on the trunk, arms, and legs.The face, feet, hands, and axillae were spared.A diagnosis of cold panniculitis was made based upon clinical presentation and histology.The pt's condition improved spontaneously without treatment within the several weeks following discontinuation of whole body cryotherapy.Whole body cryotherapy involves exposure to extremely cold dry air (below-110 degrees centigrade) in a specialized chamber or room, for 2 to 4 mins.It has been increasingly utilized within local gyms and athletic training facilities as a treatment for muscle soreness after exercise.However, a 2015 cochrane review determined there is insufficient evidence to support improvement in self-reported muscle soreness, or subjective recovery after exercise, in physically active young men, with no evidence on its use in females or elite athletes.The review further highlighted the lack of evidence regarding its safety.The u.S.Food and drug administration has not cleared or approved any whole body cryotherapy devices.Several incidents of adverse events related to whole body cryotherapy have been reported, including the death of an employee at a cryotherapy center, who was reported using the chamber outside of business hours and was subsequently found dead in the chamber the next day.There have also been case reports of adverse events following whole body cryotherapy sessions, including transient global amnesia and abdominal aortic dissection.The pt we present developed diffuse erythematous, edematous pink papules with sparing of non-exposed areas following multiple whole body cryotherapy treatments.His presentation was most consistent with cold panniculitis - inflammation of the subcutaneous fat caused by cold exposure, commonly presenting as indurated erythematous papules, plaques and/or nodules.The erythematous lesions typically become purpuric and less indurated over time.Residual hyperpigmentation may be seen for several months.Cold panniculitis is a self-limiting disorder, usually resolving in 2 to 3 weeks.No treatment is required beyond cessation of cold exposure and symptomatic relief.As whole body cryotherapy centers continue to proliferate, with many centers claiming widespread health benefits, it is important to be vigilant about potential adverse effects.Dates of use: (b)(6) 2017.Diagnosis or reason for use: post-exercise."is the product compounded: no, is the product over-the-counter: yes, event abated after use stopped or dose reduced: yes.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
WHOLE BODY CRYOTHERAPY
Type of Device
BATH, HYDRO-MASSAGE
MDR Report Key7251080
MDR Text Key99598978
Report NumberMW5075131
Device Sequence Number1
Product Code ILJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 02/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/07/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age47 YR
Patient Weight92
-
-