MAUDE Adverse Event Report: HBOT ; NONE

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Sleep Dysfunction (2517)

Event Date 08/19/2015

Event Type  Injury  

Event Description

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.

• Brand Name: HBOT
• Type of Device: NONE
• MDR Report Key: 5035582
• MDR Text Key: 24367931
• Report Number: MW5055765
• Device Sequence Number: 1
• Product Code: CBF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Report Date: 08/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 100