MAUDE Adverse Event Report: AG INDUSTRIES CPAP TUBING

Model Number AG36810

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

Patient Problems Bradycardia (1751); Headache (1880); Burning Sensation (2146)

Event Date 08/07/2016

Event Type  malfunction  

Event Description

After trying to wash out a chemical odor from my new cpap hose, i then used it for about a minute and began to experience a burning sensation in my nasal passages, a sinus headache, excessive mucus and congestion and shortness of breath.These symptoms lasted for 24 hour period which disturbed my sleep.

• Brand Name: CPAP TUBING
• Type of Device: CPAP TUBING
• Manufacturer (Section D): AG INDUSTRIES
• MDR Report Key: 5867972
• MDR Text Key: 52063165
• Report Number: MW5063999
• Device Sequence Number: 1
• Product Code: BYX
• 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: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AG36810
• Device Lot Number: 0415156AG
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 136