[24589781]
Possible stomach infection [gastric infection]; indigestion; uncomfortable feeling [discomfort]; gaseous [gas]; upset stomach; threw up [vomiting]; fever; headache; whistling in my ears [ear noises]. Case description: this case was reported by a consumer and described the occurrence of gastric infection in a (b)(6) female patient who received double salt dental adhesive cream (super poligrip original (zinc free formula)) cream (batch#: v69c, expiry date unk) for an unk indication. In (b)(6) 2014, the patient started super poligrip original (zinc free formula). In november 2014, immediately after starting super poligrip original (zinc free formula), the patient experienced indigestion, discomfort, gas and upset stomach. In (b)(6) 2015, the patient experienced gastric infection (serious criteria gsk medically significant). On an unk date, the patient experienced vomiting, fever, headache and ear noises. Super poligrip original (zinc free formula) was discontinued (dechallenge was negative). On an unk date, the outcome of the gastric infection, indigestion, discomfort, gas, upset stomach, headache and ear noises were not recovered/not resolved and the outcome of the vomiting and fever were recovered/resolved. The reporter considered the gastric infection, indigestion, discomfort, gas, upset stomach, vomiting, fever, headache and ear noises to be related to super poligrip original (zinc free formula). Additional details: ae info received 06/04/2015: a female consumer reported that she began using super poligrip original cream in (b)(6) of 2014. She said it immediately caused her to have indigestion, an uncomfortable feeling, made her gaseous, and gave her an upset stomach, which all continue to occur. The said about a week ago, she thinks the super poligrip gave her a gastric infection, further described as possible stomach infection. She said the super poligrip made her throw up, further described as throwing up pink slime, and gave her a fever, both of which have resolved. She said the super poligrip has since made her have headache and whistling in her ears. Both of these are still occurring. She has stopped using the super poligrip. See scanned page.
Patient Sequence No: 1, Text Type: D, B5