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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLASSIC HYPERBARIC; CHAMBER, HYPERBARIC
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CLASSIC HYPERBARIC; CHAMBER, HYPERBARIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Convulsion/Seizure (4406)
Event Date 08/12/2022
Event Description
Seizure in classic hyperbaric chamber.Fda safety report id# (b)(4).
 
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Brand Name
CLASSIC HYPERBARIC
Type of Device
CHAMBER, HYPERBARIC
MDR Report Key15283211
MDR Text Key298705438
Report NumberMW5111688
Device Sequence Number1
Product Code CBF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 08/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
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