MAUDE Adverse Event Report: OTSUKA AMERICA BREATHTEK SOLUTION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 01/01/2015

Event Type  Injury  

Event Description

I recently learned that you (fda) have approved the breathtek solution for use in children.This product should have been removed from the market entirely.No child or adult should experience the pain i suffer from after consuming this solution.I notified the co and registered a complaint to the fda in 2011.I suffer from burning hand and feet syndrome after consuming this product.I still suffer today.

• Brand Name: BREATHTEK SOLUTION
• Type of Device: BREATHTEK SOLUTION
• Manufacturer (Section D): OTSUKA AMERICA
• MDR Report Key: 4643317
• MDR Text Key: 5752279
• Report Number: MW5041665
• Device Sequence Number: 1
• Product Code: MSQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 77