MAUDE Adverse Event Report: SOMNOMED INC. SOMNODENT; SLEEP APPLIANCES WITH PATIENT MONITORING

Device Problem Crack (1135)

Patient Problem Sleep Dysfunction (2517)

Event Date 08/01/2020

Event Type  Injury  

Event Description

Somnomed oral device for sleep apnea cracked on bottom.Somnomed has little to no reverse logistics for repair in my opinion.My dentist had gone out of business, somnomed had no process for finding repair facility.The company insulted me the customer, took days to respond for requests for help.This device prevents sleep apnea which we know can cause sudden death.Once a dentist was found, a very poor quality and non fitting oral temporary device was provided.Told repair will take up to 3 weeks, in the meantime i am left at high risk of sleep apnea related issues.To include i am currently receiving little to no sleep.Issues for fda are: company needs a response process in place for returns related to the failure of their renew sleep business; the company must provide a temporary device that fits the patient and prevents sleep apnea while repair is made because, company should not have a 3 week lead time for a medical device that prevents life threatening issues.Company currently has the product, so unable to provide serial number.Fda safety report id# (b)(4).

• Brand Name: SOMNODENT
• Type of Device: SLEEP APPLIANCES WITH PATIENT MONITORING
• Manufacturer (Section D): SOMNOMED INC.
• MDR Report Key: 10431189
• MDR Text Key: 203857401
• Report Number: MW5096152
• Device Sequence Number: 1
• Product Code: PLC
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR
• Patient Weight: 65