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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH PRODUCTS, INC. EFFERDENT DENTURE CLEANSER; CLEANSER, DENTURE, OVER THE COUNTER
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MEDTECH PRODUCTS, INC. EFFERDENT DENTURE CLEANSER; CLEANSER, DENTURE, OVER THE COUNTER Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem Hypoglycemia (1912)
Event Date 04/22/2014
Event Type  Injury  
Event Description
A woman reported her (b)(6) year old husband experiencing accidental ingestion, kidney problems, and hypoglycemia while using efferdent denture cleanser.The woman reported that her husband used 1 tablet of efferdent denture cleanser on tuesday, (b)(6) 2014.That day the patient accidentally ingested the product, ultimately resulting in hospitalization for kidney problems (unspecified) and hypoglycemia, which were ongoing at the time of last communication with the consumer's wife on (b)(6) 2014.The woman declined to list the consumer's concomitant medications; she felt the list was too long.The consumer has a medical history of kidney problems (unspecified) and diabetes.The consumer has no known allergies.No further information was given at the time of this report.
 
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Brand Name
EFFERDENT DENTURE CLEANSER
Type of Device
CLEANSER, DENTURE, OVER THE COUNTER
Manufacturer (Section D)
MEDTECH PRODUCTS, INC.
tarrytown NY
Manufacturer Contact
660 white plains road
tarrytown, NY 10591
9145248700
MDR Report Key3841177
MDR Text Key19401155
Report Number3005372036-2014-00004
Device Sequence Number1
Product Code EFT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/15/2014
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
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/23/2014
Initial Date FDA Received05/15/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNDISCLOSED
Patient Outcome(s) Hospitalization;
Patient Age84 YR
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