FIXODENT SUPERIOR HOLD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-18 for FIXODENT SUPERIOR HOLD manufactured by Unk.

Event Text Entries

[86703556] Other serious/important medical incident: hands tingling. In (b)(6) 2017... My dentist recommended that i use fixodent superior plus when wearing my denture. Even though there was a warning regarding amount to be used, she encouraged me to use as much as i want. She gave me a sample and i bought several tubes and used the adhesive regularly as it would not hold if i drank or ate anything. Sometime in mid (b)(6) i started experiencing painful tingling in my hands every morning i woke up from a night's sleep. I had no idea why! I happened to stumble upon a site when i searched for 'medical adhesives for dentures' because my dentures were always just floating around in my mouth causing discomfort as well as embarrassment. As of today, i won't be using this product! I do plan to see my physician regarding the tingling in my hands. Hopefully the tingling will stop now that i won't be using fixodent. Is the product over-the-counter: yes. Strength: other, ounces. Quantity: other, 1 cream. Frequency: as needed. How was it taken or used: other, adhesive for denture. Did the problem stop after the person reduced the dose or stopped taking or using the product: no. Did the problem return if the person started taking or using the product again: doesn't apply. Why was the person using the product: adhesive for denture.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5072213
MDR Report Key6876091
Date Received2017-09-18
Date of Report2017-09-17
Date of Event2017-08-21
Date Added to Maude2017-09-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameFIXODENT SUPERIOR HOLD
Generic NameFIXODENT SUPERIOR HOLD
Product CodeKOO
Date Received2017-09-18
Lot Number71231
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-09-18

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