MAUDE Adverse Event Report: CLASSIC HYPERBARIC; CHAMBER, HYPERBARIC

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/12/2022

Event Type  Injury  

Event Description

Used a faulty chamber at a clinic.(b)(6).Fda safety report id# (b)(4).

• Brand Name: CLASSIC HYPERBARIC
• Type of Device: CHAMBER, HYPERBARIC
• MDR Report Key: 14416900
• MDR Text Key: 291970740
• Report Number: MW5109752
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening