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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOMNOMED INC. SOMNODENT HERBST SHIM

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SOMNOMED INC. SOMNODENT HERBST SHIM Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146); Discomfort (2330)
Event Date 10/04/2017
Event Type  Injury  
Event Description
I have sleep apnea and upon failure of a cpap machine relieving my symptoms, i chose to have a dental appliance made.My first one was made by somnodent in 2015.I had great success with it, but due to extensive dental restoration, i needed to replace that unit with a new one.In (b)(6) of 2016, i received my new somnodent dental appliance and looked forward to a similar experience as with original unit.The replacement unit was called a herbst shim and was clear blue acrylic unlike my previous unit.Within a few days of receiving this new appliance (in hindsight) i went to my internist for an unrelated issue and mentioned that the soft tissue inside my mouth was sore and i had cracks in the corners of my mouth.(b)(6) asked if i lick my lips and when i answered "i guess so" she suggested that i stop and meanwhile use rx clotrimazole 1% cream on my lips and corners of my mouth.I told her that i am in a swimming and several times a week and is it possible that i picked up a bacteria.She said to use the ointment for 1-3 weeks to see if that helps.She also suggested using aquaphor ointment on my lips to keep them moist.I followed these directions and found some relief but not enough.When i had my next visits with my internist in (b)(6) and again in (b)(6) 2017, i said that the ointment was not helping and that the mouth soreness persists.Again i chalked it up to something i was experiencing from the swimming pool or perhaps someone i kissed had a viral infection.I even stopped kissing my husband on the face as i was afraid to pass this mouth soreness and cracked lip corners on to him.Since about (b)(6) 2016, i had not been able to eat certain foods due to the soft tissue soreness inside my mouth.Fresh fruit and vinegar burned the worst when i would eat them so i tried to avoid them although i am a salad eater and prefer vinegar and oil dressing over any other dressings.In (b)(6) this year, i visited my nurse practitioner and mentioned how horrible this 'mouth issue' was and that i really needed to find what it is and remedy it.She ordered several mouth cultures to determine if it is bacterial or fungal.She felt it could be contagious.While the cultures were being run she insisted that i see an ent dr.I made an appt for (b)(6) and saw (b)(6), md.Her diagnosis was bms-burning mouth syndrome.She gave me several sheets of info about bms including a link to the (b)(6) website about it as well as the national institutes of health website on bms.The (b)(6) site listed my symptoms as the first 2 symptoms "a burning or scalded sensation that most commonly affects your tongue, but may also affect your lips, gums, palate, throat or whole mouth." "a sensation of dry mouth with increased thirst." it was the nih site that described this condition as "damage to the nerves that control pain and taste." the site listed common causes and the 2nd one listed was "allergies to dental products, dental materials (usually metals)." (nih publication no.16-6288 july 2016).I now knew i had to stop using the somnodent herbst dental appliance that i had used almost every night for the past year.I did not use it for 3 nights.On the 4th night, i used the appliance and awoke the next morning to a horrible vision in my mirror of a totally swollen lower mouth and lip protruding out with 2 raw and painful sores inside my lower lip and cheek.I called my sleep apnea dental specialist and reported my findings.To recheck my allergy to the device i slept one night with it taped to my forearm.The reaction was clear the next morning seeing welts in the design of the appliance.Seeing my allergic response, my dental specialist dr.(b)(6), dds in (b)(6) took new impressions so that a replacement dental appliance could be made by the somnodent company figuring there was a freak occurrence with the appliance i had been using.The replacement came several weeks later and before using it in my mouth, i again taped it to my forearm for one night's sleep.The next morning i awoke to welts again in the shape of the appliance.Since then, which was in (b)(6), my mouth issues have totally disappeared, thank goodness.I do not seem to have any long term affects.My dental specialist has ordered a difference sleep apnea appliance form a different mfr.I am still waiting for it to arrive so i can resume safe and good sleep during the night.I've been without an appliance for almost 4 months.Since my apnea causes me to stop breathing this is a vital part of my quality of life.It took a year to figure out what caused my symptoms.I can't help but think that there are other folks out there who have no idea that a dental appliance like somnodent's could cause these issues.Please take appropriate action and feel free to contact me if further info is needed.By the way.So far this incident has cost over $(b)(6) in out of pocket expenses to me.It has cost (b)(6) of dollars.And it is costing my dental specialist hundreds of dollars in time and materials.Herbst shim.
 
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Brand Name
SOMNODENT HERBST SHIM
Type of Device
SOMNODENT HERBST SHIM
Manufacturer (Section D)
SOMNOMED INC.
MDR Report Key7048215
MDR Text Key92723908
Report NumberMW5073428
Device Sequence Number1
Product Code LRK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age70 YR
Patient Weight68
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