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).
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