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Vomiting [vomiting] sick/still making her feel sick [sickness] nauseous [nausea] really bad tummy pain / belly ache [stomach pain] she does it about three times a day, it does not seem to be sticking properly [device used for unapproved schedule] loses weight [weight loss] when she eats it going down [accidental device ingestion] case description: this case was reported by a consumer via call center representative and described the occurrence of vomiting in a (b)(6) female patient who received double salt dental adhesive cream (polident max seal denture adhesive cream) cream (batch number unk, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started polident max seal denture adhesive cream.On an unknown date, an unknown time after starting polident max seal denture adhesive cream, the patient experienced vomiting, sickness, nausea, stomach pain, device used for unapproved schedule, weight loss, accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant) and product complaint.The patient was treated with metoclopramide hydrochloride (maxolon) and oxycodone (oxycodon).On an unknown date, the outcome of the vomiting, sickness, nausea, stomach pain, device used for unapproved schedule, weight loss, accidental device ingestion and product complaint were unknown.It was unknown if the reporter considered the vomiting, sickness, nausea, stomach pain, device used for unapproved schedule, weight loss and accidental device ingestion to be related to polident max seal denture adhesive cream.Additional information : initial and follow up information was processed together.Adverse event information was received via call center representative on 07 july2021.The reporter (consumer's husband) stated that,"i am just enquiring about the warning on polident max seal denture adhesive cream.My wife has been using it and she has been to gastroenterologist or so like whatever.If i look at her tummy now is really angry and she does wear dentures.Then, she is looking at it all after she uses it, she really gets like vomiting, sick, nauseous and really bad tummy pain and stuff like that.Is it going to cause such like a pain and stuff? she cooks and she eats like anything too spicy.She loves curry and stuff like that and it too strong.Vinegar things to do it as well like a sausage.Also, some fast food products.Chicken nuggets and garlic, stuff like that.I keep it as basic as i can for her but something still, you know.Like steak, stuff like that, a little bit, it is still making her feel sick.Everything like that but not to the extent of folding her eyes or such.I have noticed when she puts the stuff on it, she does it about three times a day, it doesn't seem to be sticking properly whether the denture has a problem but they pretty new and it is a second set and been aligned and everything but it doesn't seem to want to work or maybe she is using too much, i don't know.It is not holding her teeth for a day.Yes, she is using more than once because it becomes loose.Yes, it has been aligned and everything is in.She has been to her gastroenterologist.She has been done all things but her tummy is really angry and her doctor told us which is a specialist and she has done every test going, and none of on their journals is something that no can work out.When it happened was after she got a second set of dentures which is couple of years ago that when it was started.She has been to a care like a they put little scratches on your arm like for allergy test or stuff.She has done a tube down on her throat, everything like series of blood test, x-ray.She has done with a camera to be inserted in the throat.What i really want to know is, do you know of anything that can stop or have information in the tummy or have you got anything to do with it? she loses weight or stuff everything from it.It depends what she eats.It is just weird.We have been to everything.Is there something she can take on this? she is on a maxolon tablet or like something wafers to stop the nausea and all that like vomiting.She is being going on this for years and she is on oxycodone for her tummy pain in it like which is morphine.We are just trying to work what the hell are these.She has been using it polident three times a day because it doesn't stick fully.Maybe we need to see another dentist to see her dentures if it is okay.She is got another specialist appointment in august and she is going to repeat again (procedures).Is there anything in your books at all to stop this? yes, she is still experiencing it.She has been to the doctor and everywhere.Just want to find out for her to tummy down.She had two and half years or whatever it is i can't remember the exact time but it been a while.What other products can she use? have you got any products? when she eats it going down to where she has a salty vinegar chips out of the pocket.She gets a belly ache.All i am trying to do is to find out if it is something that can be done? if you have same problems with other people or so what? if she can take charcoal tablet or maybe?." follow up information was received on 09 july 2021 from quality assurance department regarding complaint (b)(4) and case number (b)(4).No sample was returned for this complaint so a full investigation could not be completed.The batch number provided is also invalid.On this basis we are unable to investigate this complaint further.All of the documentation pertinent to a specific lot of finished product is contained in a [?]batch envelope'.Prior to the disposition of the product, the contents of each batch envelope is reviewed & approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verifies that all test results meet specification requirements.Should valid lot details be confirmed the case will be opened and further investigate will be performed on site.Complaint conclusion: unsubstantiated.
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