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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DENTU CREME TOOTHPASTE; TOOTHPASTES
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BLOCK DRUG CO., INC. POLIDENT DENTU CREME TOOTHPASTE; TOOTHPASTES Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Pain (1994); Anxiety (2328); Reaction (2414)
Event Type  Other  
Event Description
Event verbatim [lower level term] (related symptoms if any separated by commas).Allergic reaction [hypersensitivity].Feeling of death [anxiety].Hard time breathing [dyspnea].Throat closing up [throat tightness].Throat hurting [oropharyngeal pain].Product complaint [product quality issue].Case description: this case was reported by a consumer and described the occurrence of allergic reaction in a (b)(6) female patient who rec'd double salt denture cleanser (polident overnight denture cleanser tablets) unk (batch number mg2412, expiry date unk) for product used for unk indication.Concurrent medical conditions included drug allergy.On an unk date, the patient started polident overnight denture cleanser tablets.On an unk date, an unk time after starting polident overnight denture cleanser tablets, the patient experienced allergic reaction, drug allergy, impending doom, difficulty breathing and product complaint.On an unk date, the patient experienced throat constriction and throat pain.Polident overnight denture cleanser tablets was discontinued (dechallenge was negative).On an unk date, the outcome of the allergic reaction, drug allergy, impending doom, difficulty breathing and product complaint were not recovered/not resolved and the outcome of the throat constriction and throat pain were not recovered/not resolved.It was unk if the reporter considered the allergic reaction, drug allergy, impending doom, difficulty breathing, throat constriction, and throat pain to be related to polident overnight denture cleanser tablets.This report is made by gsk without prejudice and does not imply and admission or liability for the incident or its consequences.Additional information included: consumer called in to report that she had an allergic reaction and almost died.Her throat was hurting and he has a hard time breathing.She took a shot of her epi pen and benadryl and is feeling a bit better.She has not gone yet to see her doctor.She also mentioned that she uses the polident dentu creme toothpaste.She is allergic to sulfur.She also reported a product complaint since she has been using the product for 13 years and this is the first time it happened to her.Ae revision (b)(6) 2015: the adverse event of allergic to sulfa as been removed as this is a pre-existing condition.The consumer reported she has used this same product for 13 years and never had an issue.She use the product and had a severe allergic reaction that she treated with an epi pen and benadryl.She further described that her throat started to hurt, and she felt her throat closing up and had difficulty breathing.She reported she almost died because of the allergic reaction.She reported that she is feeling a bit better.
 
Manufacturer Narrative
Adverse event follow up information was received on september 22, 2015 via return authorization form.In this form, the physician has confirmed the details of health care professional.
 
Manufacturer Narrative
Number 1020379-2015-00010 is associated with argus case (b)(4), polident dentu creme toothpaste.
 
Event Description
Allergic reaction [allergic reaction].Feeling of death [anxiety].Hard time breathing [difficulty breathing].Throat closing up [throat tightness].Throat hurting [oropharyngeal pain].Case description: this case was reported by a consumer and described the occurrence of allergic reaction in a (b)(6) old female patient who received double salt denture cleanser (polident overnight denture cleanser tablets) unknown (batch number mg2412, expiry date unknown) for product used for unknown indication.Concurrent medical conditions included drug allergy.On an unknown date, the patient started polident overnight denture cleanser tablets.On an unknown date, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced allergic reaction, drug allergy, impending doom, difficulty breathing and product complaint.On an unknown date, the patient experienced throat constriction and throat pain.Polident overnight denture cleanser tablets was discontinued (dechallenge was negative).On an unknown date, the outcome of the allergic reaction, drug allergy, impending doom, difficulty breathing and product complaint were not recovered/not resolved and the outcome of the throat constriction and throat pain were not recovered/not resolved.It was unknown if the reporter considered the allergic reaction, drug allergy, impending doom, difficulty breathing, throat constriction and throat pain to be related to polident overnight denture cleanser tablets.Additional information included: consumer called in to report that she had an allergic reaction and almost died.Her throat was hurting and the she had a hard time breathing.She took a shot of her epi pen of benadryl and is feeling a bit better.She has not gone yet to see her doctor.She also mentioned that she uses the polident dentu creme toothpaste.She is allergic to sulfur.She also reported a product complaint since she has been using the product for 13 years and this is the first time it happened to her.Ae revision 29 june 2015: the adverse event of allergic to sulfa as been removed as this is a pre-existing condition.The consumer reported she has used this same product for 13 years and never had an issue.She used the product and had a severe allergic reaction that she treated with an epi pen and benadryl.She further described that her throat started to hurt, and she felt her throat closing up and had difficulty breathing.She reported she almost died because of the allergic reaction.She reported that she is feeling a bit better.Adverse event follow up information was received on 22 september 2015 via return authorization form.In this form, the physician has confirmed the details of health care professional.In the initial case polident dentu creme toothpaste was added as a co-suspect drug.Follow-up information was received on 31 march 2016 from the quality assurance (qa) department regarding complaint number (b)(4).Quality investigation report included that the consumer only submitted one tablet for evaluation which was not enough to allow for testing.The odor, ph, oxygen content, loss on drying, enzyme id, disintegration time tests were performed.No issues noted in the batch file.Nothing wrong was find out with this product.No further information was provided.
 
Manufacturer Narrative
This report is associated with argus (b)(4), polident dentu creme toothpaste.
 
Event Description
Case description: this case was reported by a consumer and described the occurrence of allergic reaction in a (b)(6) female patient who received double salt denture cleanser (polident overnight denture cleanser tablets) unknown (batch number mg2412, expiry date unknown) for product used for unknown indication.Concurrent medical conditions included drug allergy.On an unknown date, the patient started polident overnight denture cleanser tablets.On an unknown date, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced allergic reaction, drug allergy, impending doom, difficulty breathing and product complaint.On an unknown date, the patient experienced throat constriction and throat pain.Polident overnight denture cleanser tablets was discontinued (dechallenge was negative).On an unknown date, the outcome of the allergic reaction, drug allergy, impending doom, difficulty breathing and product complaint were not recovered/not resolved and the outcome of the throat constriction and throat pain were not recovered/not resolved.It was unknown if the reporter considered the allergic reaction, drug allergy, impending doom, difficulty breathing, throat constriction and throat pain to be related to polident overnight denture cleanser tablets.Additional information included: consumer called in to report that she had an allergic reaction and almost died.Her throat was hurting and the she had a hard time breathing.She took a shot of her epi pen of benadryl and is feeling a bit better.She has not gone yet to see her doctor.She also mentioned that she uses the polident dentu creme toothpaste.She is allergic to sulfur.She also reported a product complaint since she has been using the product for 13 years and this is the first time it happened to her.Ae revision 29 june 2015: the adverse event of allergic to sulfa as been removed as this is a pre-existing condition.The consumer reported she has used this same product for 13 years and never had an issue.She used the product and had a severe allergic reaction that she treated with an epi pen and benadryl.She further described that her throat started to hurt, and she felt her throat closing up and had difficulty breathing.She reported she almost died because of the allergic reaction.She reported that she is feeling a bit better.Adverse event follow up information was received on 22 september 2015 via return authorization form.In this form, the physician has confirmed the details of health care professional.In the initial case polident dentu creme toothpaste was added as a co-suspect drug.Follow-up information was received on 31 march 2016 from the quality assurance (qa) department regarding (b)(4).Quality investigation report included that the consumer only submitted one tablet for evaluation which was not enough to allow for testing.The odor, ph, oxygen content, loss on drying, enzyme id, disintegration time tests were performed.No issues noted in the batch file.Nothing wrong was find out with this product.No further information was provided.Follow-up information was received on 08 april 2016 from the quality assurance (qa) department regarding product complaint (b)(4).Quality investigation report included that, no sample was received.No issues were noted in the batch file.The case would be reopened if the sample was received.No further information was provided.Revision of this case on 19 april 2016, to clarify follow-up information received on 08 april 2016 from quality assurance (qa): the qa investigation report ((b)(4)) received on 08 april 2016, was one of two product complaints reported in this case for polident overnight denture cleanser tablets.The first complaint was from the consumer stating that she has been using the product for 13 years and this is the first time she has experienced the reported adverse events while using the product.The consumer returned one or two tablets which was not enough of the product to allow for quality testing.The second product complaint was reported by the gsk consumer health care call center representative.She reported product mislabeling in that she suspected the expiration on the product box was incorrect due to the product's shelf life.She believed the product expiration date should be july 2015 instead of july 2014.
 
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Brand Name
POLIDENT DENTU CREME TOOTHPASTE
Type of Device
TOOTHPASTES
Manufacturer (Section D)
BLOCK DRUG CO., INC.
memphis TN
Manufacturer (Section G)
GSK
Manufacturer Contact
p.o. box 13398
research triangle park, NC 27709
8888255249
MDR Report Key4911484
MDR Text Key6056389
Report Number1020379-2015-00010
Device Sequence Number1
Product Code EFT
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,consumer,health profession
Type of Report Initial,Followup,Followup,Followup
Report Date 06/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Initial Date Manufacturer Received 06/25/2015
Initial Date FDA Received07/10/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received09/30/2015
04/06/2016
04/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other;
Patient Age43 YR
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