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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALL DENTAL ADHESIVES; ADHESIVE, DENTURE, CARBOXYMETHYL CELLULOSE SODIUM

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ALL DENTAL ADHESIVES; ADHESIVE, DENTURE, CARBOXYMETHYL CELLULOSE SODIUM Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Diarrhea (1811); Pain (1994); Anxiety (2328); Sleep Dysfunction (2517)
Event Date 08/08/2019
Event Type  Injury  
Event Description
I have a high intolerance to salicylates, preservatives food color, flavors et al.One substance i cannot tolerate is cellulose gum.I get diarrhea, muscle pain, skin problems, eye mucous (for lack of proper terminology), anxiety, lack of sleep, just to mention a few of my many symptoms.I started wearing dentures, uppers, in or about (b)(6) 2019.I am in the beginning process of trying to find dentures i will not be allergic to.If you have any info on dentures i would appreciate your help.Right now i am trying to find a denture adhesive that i can use.Everyone i researched so far fas cellulose gum.I can't tolerate it.Stopped wearing the dentures on (b)(6) 2019.Need help finding a salicylate fee / cellulose fee denture adhesive.Don't know who to turn to.Help.Product type: otc.Did the problem stop after use stopped/reduced? yes.Did the problem return if started taking? doesn't apply.Quantity: 1 na.Frequency: daily.How was it taken or used: dental adhesive.Estimate of duration: 8 months.Reason for use: keep dentures in.
 
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Brand Name
ALL DENTAL ADHESIVES
Type of Device
ADHESIVE, DENTURE, CARBOXYMETHYL CELLULOSE SODIUM
MDR Report Key8896682
MDR Text Key154683835
Report NumberMW5089069
Device Sequence Number1
Product Code KOL
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 08/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date08/08/2019
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/14/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age69 YR
Patient Weight95
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