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

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).

• 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 Key: 5006696
• MDR Text Key: 23225092
• Report Number: MW5055401
• Device Sequence Number: 1
• Product Code: KOL
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 4D1
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR