CRYOTHERAPY CRYOSAUNA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-21 for CRYOTHERAPY CRYOSAUNA manufactured by Impact Cryotherapy (atlanta Ga).

Event Text Entries

[145920918] I spoke with dr (b)(6), fda center for devices and radiological health, on (b)(6) and he encouraged me to submit this report. On (b)(6) 2018 at approx 5:45 pm, i had a heart attack in a whole body cryotherapy (wbc) chamber contained within a van parked near the office of my physical therapist in (b)(6). The pt who owns and operates this is (b)(6). All van doors were closed and mr (b)(6) said he had an oxygen monitor. The unit used liquid nitrogen. With pressure and pain in my chest, i immediately went to the emergency room and was admitted to (b)(6) hosp in (b)(6). An ekg showed normal results. The attending emergency room physician, dr (b)(6), said my blood work showed elevated heart enzymes (troponin). A second blood test indicated my troponin levels were rising further. Dr (b)(6) said this indicated heart attack. I was given two doses of nitroglycerin which stopped the pain and pressure in my chest. I was admitted to the hosp. The attending cardiologist, dr (b)(6), performed a cardiac cath the next morning and reported heart damage. He observed no blockage and little plaque. He said he believed my arterial veins constricted from the wbc cold temperature and my heart spasmed. I've previously had approx. 15 wbc sessions. I use wbc to reduce inflammation caused by rheumatoid arthritis. I'm (b)(6), physically fit and have been a runner for 40 years. I understand wbc is unregulated. I hope my info will prevent this event from happening to others using wbc.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086780
MDR Report Key8627723
Date Received2019-05-21
Date of Report2018-12-11
Date of Event2018-12-04
Date Added to Maude2019-05-21
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 NameCRYOTHERAPY CRYOSAUNA
Product CodeILJ
Date Received2019-05-21
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerIMPACT CRYOTHERAPY (ATLANTA GA)


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-05-21

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