MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS

Lot Number MG2412

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Emotional Changes (1831); Hypersensitivity/Allergic reaction (1907); Pain (1994); Anxiety (2328); Sore Throat (2396); Chest Tightness/Pressure (2463)

Event Type  Injury  

Event Description

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 pt who received 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 pt started polident overnight denture cleanser tablets.On an unk date, an unk time after starting polident overnight denture cleanser tablets, the pt experienced allergic reaction, drug allergy, impending doom, difficulty breathing and product complaint.On an unk date, the pt 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.Add'l info included: consumer called in to report that she had an allergic and almost died.Her throat was hurting and 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 june 29, 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.

Event Description

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

This report is associated with argus (b)(4), polident overnight denture cleanser tablets.Device qa results: the consumer only submitted one tablet for evaluation which was not enough to allow for testing.Here are the results from the testing performed at release: odor - minty, ph - 8.3 spec 7.7-8.9, oxygen content - 3.6% spec 2.7% minimum, loss on drying - 0.20% spec 0.80% maximum, enzyme id - passes test, disintegration time - 2 min 13 sec spec 15 minutes maximum.Qa investigation found nothing wrong with this product.No issues noted in the batch file.

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) 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 (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 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 (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

Tis report is associated with argus (b)(4), polident overnight denture cleanser tablets.Device qa results: the consumer only submitted one tablet for evaluation which was not enough to allow for testing.Here are the results from the testing performed.At release: odor - minty, ph - 8.3 spec 7.7-8.9, oxygen content - 3.6% spec 2.7% minimum, loss on drying - 0.20% spec 0.80% maximum, enzyme id - passes test, disintegration time - 2 min 13 sec spec 15 minutes maximum.Qa investigation found nothing wrong with this product.No issues noted in the batch file.Device qa results for second product complaint: no sample received.No issues noted in the batch file.

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 (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 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 reference id 435103.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.

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 4911479
• MDR Text Key: 16882368
• Report Number: 1020379-2015-00011
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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
• Device Lot Number: MG2412
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 07/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/30/2015; 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 Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 43 YR