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

Lot Number 4D1

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Emotional Changes (1831); Pain (1994); Burning Sensation (2146); Sleep Dysfunction (2517); Cognitive Changes (2551)

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 effect, restless and sleepless throughout the night, and fluctuating consciousness while using effergrip denture adhesive cream / zinc free formula.On 06/17/2015, the consumer reported using one application, amount unk, twice of effergrip denture adhesive cream / zinc free formula.After starting effergrip denture cream / zinc free formula, she experienced a burning sensation, pain, dentures fell out of her mouth, lack of effect, and restless and sleepless throughout the night.On 06/18/2015, 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.

• Brand Name: EFFERGRIP DENTURE ADHESIVE CREAM / ZINC FREE
• Type of Device: DENTURE ADHESIVE CREAM, OTC
• Manufacturer (Section D): MEDTECH PRODUCTS, INC.; tarrytown NY
• Manufacturer Contact: 660 white plains rd; tarrytown, NY 10591 ; 9145248700
• MDR Report Key: 4995443
• MDR Text Key: 23085279
• Report Number: 3002647523-2015-00002
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Not Applicable
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2015
• Date Device Manufactured: 04/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR