MAUDE Adverse Event Report: TOMED, GMBH. SOMNOGUARD MANDIBULAR ADVANCEMENT DEVICE; DEVICE, ANTI-SNORING

Model Number SOMNOGUARD AP PRO

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2020

Event Type  malfunction  

Event Description

On the morning of (b)(6) 2020, i was sleeping but beginning to wake up when i felt something on my tongue.I had my oral appliance in place for the treatment of my sleep apnea.It was difficult to maneuver my tongue to get the object to a point where i would not aspirate it or swallow it.After getting it under my tongue, i removed the appliance and discovered the screw in the appliance had broken.The nut remained attached to the other portion of the screw still in the appliance.Had i not been in the state between sleep and awakening, i would have aspirated the screw and been seriously injured if not killed.This incident was a near miss to say the least.Fda safety report id #: (b)(4).

• Brand Name: SOMNOGUARD MANDIBULAR ADVANCEMENT DEVICE
• Type of Device: DEVICE, ANTI-SNORING
• Manufacturer (Section D): TOMED, GMBH.
• MDR Report Key: 10104960
• MDR Text Key: 194046207
• Report Number: MW5094760
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOMNOGUARD AP PRO
• 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): Other
• Patient Age: 58 YR
• Patient Weight: 235