MAUDE Adverse Event Report: APNEA SCIENCES CORPORATION SNORE RX; DEVICE, ANTI-SNORING-SNORERX

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 08/20/2018

Event Type  Injury  

Event Description

I purchased a "snore rx" device.I used the device according to mfr instructions.In less than a year, i had intense jaw pain and the inability to close and clench my teeth together.As a result of using the device, my quality of life has been severely impacted.Inability to fully chew food items, constant jaw pain and inflammation.Significant expenses associated with treatment for comfort and pain.I have been working with my dentist, maxillofacial surgeon and now, orthodontist to correct the movement my teeth have gone through and to treat significant pain.A $(b)(6) device will cost me around $(b)(6).

• Brand Name: SNORE RX
• Type of Device: DEVICE, ANTI-SNORING-SNORERX
• Manufacturer (Section D): APNEA SCIENCES CORPORATION
• MDR Report Key: 8071031
• MDR Text Key: 127340861
• Report Number: MW5081263
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• 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: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 149