HBOT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-23 for HBOT manufactured by .

Event Text Entries

[24367931] My parents, unfortunately fervent believers in alternative medicine woo, coerced me into doing hbot therapy and now my leg muscles are so sore that it keeps me from sleep. I am unaware of all the medications i'm on (at least 10) because my mother is a control freak and won't even remind me what medications i've been prescribed. She just gives them all to me each night in a tiny ziplock bag. Cymbalta is the only one i can think of off the top of my head.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5055765
MDR Report Key5035582
Date Received2015-08-23
Date of Report2015-08-23
Date of Event2015-08-19
Date Added to Maude2015-08-27
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 NameHBOT
Generic NameNONE
Product CodeCBF
Date Received2015-08-23
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2015-08-23

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