[5812599]
Dizziness, swallowed the product [accidental device ingestion]. Case description: this case was reported by a consumer via call center representative and described the occurrence of dizziness in a female patient who received double salt dental adhesive cream (polident denture adhesive, flavor free) unknown (batch number u14151, expiry date 04/07/2017) for drug use for unknown indication. Concurrent medical conditions included diabetes. On an unknown date, the patient started polident denture adhesive, flavor free. On an unknown date, an unknown time after starting polident denture adhesive, flavor free, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. The reporter considered the dizziness to be probably related to polident denture adhesive, flavor free. Additional details: the consumer bought polident adhesive cream 15 grams from a drugstore. The consumer has been using the product several times, but this time she had increased amount of cream for the lower denture. The cream leaked out from the denture. The consumer experienced dizziness and the event still occurred during her call with the call center agent. The consumer did not consult a physician about this. The consumer also reported that she has diabetes and has taken medication for the condition, but would not normally experience dizziness. Dizziness only occurred when she used more amount of the adhesive cream. The event would not occur if she used the normal amount. The consumer mentioned that she was satisfied with the efficacy of the product and was willing to be contacted for further follow-up. Follow- up information received on 10/24/2014: the patient was (b)(6). The dizziness occurred due to the patient accidentally swallowing the polident adhesive cream because she was using too much of it. The event would not occur if using a normal amount of the cream. Treatment with polident adhesive cream was withdrawn on (b)(6) 2014. Due to the event, she consulted an hcp and was advised to stop using the product as she may be allergic to the ingredients. At the time of reporting the dizziness was resolving. Error correction: as determined causality updated to meet regulatory requirements.
Patient Sequence No: 1, Text Type: D, B5