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 2018-02-07 for WHOLE BODY CRYOTHERAPY manufactured by Unk.

Event Text Entries

[99598978] 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. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5075131
MDR Report Key7251080
Date Received2018-02-07
Date of Report2018-02-06
Date of Event2017-09-18
Date Added to Maude2018-02-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameWHOLE BODY CRYOTHERAPY
Generic NameBATH, HYDRO-MASSAGE
Product CodeILJ
Date Received2018-02-07
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-02-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.