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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH PRODUCTS EFFERDENT DENTURE CLEANSER
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MEDTECH PRODUCTS EFFERDENT DENTURE CLEANSER Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Rash (2033)
Event Date 08/01/2014
Event Type  Injury  
Event Description
Periodontist recommended efferdent dental cleanser mouth guard.After 4 months, a severe rash developed that required extensive steroid treatment.The offending chemical is a persulfate, a "known allergen" is posted on the label.Date the person first started taking or using the product: (b)(6) 2014.Date the person stopped taking or using the product: (b)(6) 2014.Why was the person using the product (such as what condition was it supposed to treat: these rinses "clean" the dental appliance of bacteria.Severe body rash and mouth sores at gumline.My regular dentist said to never use any dental cleanser (efferdent and others) because of the extreme allergic reaction to persulfate, a "known allergen." the fda knows about this and recommends companies "find an alternative." i cannot believe that only (b)(6) people have complained about this chemical! hives and severe rash requiring 8 weeks of prednisone to treat.
 
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Brand Name
EFFERDENT DENTURE CLEANSER
Type of Device
EFFERDENT DENTURE CLEANSER
Manufacturer (Section D)
MEDTECH PRODUCTS
MDR Report Key4484030
MDR Text Key16994655
Report NumberMW5040561
Device Sequence Number1
Product Code EFT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/19/2015
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 Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/30/2015
Patient Sequence Number1
Treatment
CENTRUM SILVER; CITRACAL; L-LYSINE; TYLENOL
Patient Outcome(s) Other; Disability;
Patient Age73 YR
Patient Weight59
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