FDA.reportPublic FDA data

MAUDE MDR 7203020

MDR report key
7203020
Report number
MW5074673
Event key
0
Event type
3
Date of event
2017-12-23
Date received
2018-01-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KOLD WHOLE BODY CRYOTHERAPYIMMERSION HYDROBATHILJI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-170

Event Narratives#

D

Patient 1

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)