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

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.

• Brand Name: ALL DENTAL ADHESIVES
• Type of Device: ADHESIVE, DENTURE, CARBOXYMETHYL CELLULOSE SODIUM
• MDR Report Key: 8896682
• MDR Text Key: 154683835
• Report Number: MW5089069
• Device Sequence Number: 1
• Product Code: KOL
• 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: 08/12/2019

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 Date: 08/08/2019
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 69 YR
• Patient Weight: 95