• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH PRODUCTS, INC. EFFERGRIP DENTURE ADHESIVE CREAM/ ZINC FREE FORMULA

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTECH PRODUCTS, INC. EFFERGRIP DENTURE ADHESIVE CREAM/ ZINC FREE FORMULA Back to Search Results
Lot Number 4D1
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Pain (1994); Burning Sensation (2146); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)
Event Date 06/17/2015
Event Type  Injury  
Event Description
An (b)(6) female consumer reported experiencing a burning sensation, pain, dentures fell out of her mouth, lack of affect, restless and sleepless throughout the night, and fluctuating consciousness while using effergrip denture adhesive cream/ zinc free formula.On (b)(6) 2015, the consumer reported using one application, amount unk, twice of effergrip denture adhesive cream/zinc free formula.After starting effergrip denture adhesive cream/zinc free formula, she experienced a burning sensation, pain, dentures fell out of her mouth, lack of affect, and restless and sleepless throughout the night.On (b)(6) 2015, she experienced fluctuating consciousness, almost incoherent, while putting soap and water on a paper towel and attempting to rinse her gums to relieve the hot burning sensation.The next morning, her husband called the emt and she went to the emergency room.The consumer is currently taking medications daily, however, they are unspecified.Her medical history is unk and she was not pregnant at the time of incident.(b)(6).Mfr report number#: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EFFERGRIP DENTURE ADHESIVE CREAM/ ZINC FREE FORMULA
Type of Device
DENTURE ADHESIVE
Manufacturer (Section D)
MEDTECH PRODUCTS, INC.
660 white plains road
tarrytown NY 10591
MDR Report Key5006696
MDR Text Key23225092
Report NumberMW5055401
Device Sequence Number1
Product Code KOL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Medical Equipment Company Technician/Representative
Report Date 07/30/2015
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 No Information
Device Lot Number4D1
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/04/2015
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age86 YR
-
-