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

Device Problem Use of Device Problem (1670)

Patient Problems Erosion (1750); Death (1802); Blood Loss (2597)

Event Type  Death  

Manufacturer Narrative

Mfr 1020379-2017-00032 is associated with argus case (b)(4), polident.

Event Description

Internal bleeding from upper gi tract [gastrointestinal bleeding], corrosion in upper gi tract [gastrointestinal erosion].Case description: this case was reported by a consumer via call center representative and described the occurrence of gastrointestinal bleeding in a male patient who received polident (polident (unknown)) unknown for dental cleaning.Concurrent medical conditions included dementia.On an unknown date, the patient started polident (unknown).On an unknown date, an unknown time after starting polident (unknown), the patient experienced gastrointestinal bleeding (serious criteria death and gsk medically significant), gastrointestinal erosion (serious criteria gsk medically significant) and wrong technique in device usage process.On an unknown date, the outcome of the gastrointestinal bleeding was fatal and the outcome of the gastrointestinal erosion and wrong technique in device usage process were not reported.The reported cause of death was gastrointestinal bleeding.The reporter considered the gastrointestinal bleeding and gastrointestinal erosion to be related to polident (unknown).Additional details: the reporter stated via email to please consider putting a large warning on polident denture cleansers, so people who use the products can clearly see the danger of chewing or swallowing the product.She stated that when seniors begin to get the start of dementia, they can do unwise things.She reported that she had this experience with a loved one, who began to chew the product to clean his teeth.The reporter stated that they were not sure if this was often, but when she saw him doing this, she told him he shouldn't be doing this.The reporter indicated that at the time she didn't think of the great danger, or she would have been more aggressive in her instruction, as she now knows the corrosive nature of this product.She stated that she truly believed it caused corrosion in his upper gi tract from where he had internal bleeding.She reported that he ended up passing away before a blood transfusion could be done.The reporter stated to please put a large warning not to chew or swallow this product because of its corrosive ingredients, so seniors or their care givers would be sure to notice and definitely be aware.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of gastrointestinal bleeding in a male patient who received polident (polident (unknown)) unknown for dental cleaning.Concurrent medical conditions included dementia.On an unknown date, the patient started polident (unknown).On an unknown date, an unknown time after starting polident (unknown), the patient experienced gastrointestinal bleeding (serious criteria death and gsk medically significant), gastrointestinal erosion (serious criteria gsk medically significant) and wrong technique in device usage process.On an unknown date, the outcome of the gastrointestinal bleeding was fatal and the outcome of the gastrointestinal erosion and wrong technique in device usage process were not reported.The reported cause of death was gastrointestinal bleeding.The reporter considered the gastrointestinal bleeding and gastrointestinal erosion to be related to polident (unknown).Additional details: the reporter stated via email to please consider putting a large warning on polident denture cleansers, so people who use the products can clearly see the danger of chewing or swallowing the product.She stated that when seniors begin to get the start of dementia, they can do unwise things.She reported that she had had this experience with a loved one, who began to chew the product to clean his teeth.The reporter stated that they were not sure if this was often, but when she saw him doing this, she told him he shouldn't be doing this.The reporter indicated that at the time she didn't think of the great danger, or she would have been more aggressive in her instruction, as she now knows the corrosive nature of this product.She stated that she truly believed it caused corrosion in his upper gi tract from where he had internal bleeding.She reported that he ended up passing away before a blood transfusion could be done.The reporter stated to please put a large warning not to chew or swallow this product because of its corrosive ingredients, so seniors or their care givers would be sure to notice and definitely be aware.Follow up information received on 19-apr-2017 (qa report received): the reporter stated: "i am unable to determine the cause or substantiate this claim.".

Manufacturer Narrative

Report 1020379-2017-00032 is associated with argus (b)(4), polident overnight denture cleanser tablets.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of gastrointestinal bleeding in a male patient who received polident (polident (unknown)) unknown for dental cleaning.Concurrent medical conditions included dementia.On an unknown date, the patient started polident (unknown).On an unknown date, an unknown time after starting polident (unknown), the patient experienced gastrointestinal bleeding (serious criteria death and gsk medically significant), gastrointestinal erosion (serious criteria gsk medically significant) and wrong technique in device usage process.On an unknown date, the outcome of the gastrointestinal bleeding was fatal and the outcome of the gastrointestinal erosion and wrong technique in device usage process were not reported.The reported cause of death was gastrointestinal bleeding.The reporter considered the gastrointestinal bleeding and gastrointestinal erosion to be related to polident (unknown).Additional details: the reporter stated via email to please consider putting a large warning on polident denture cleansers, so people who use the products can clearly see the danger of chewing or swallowing the product.She stated that when seniors begin to get the start of dementia, they can do unwise things.She reported that she had this experience with a loved one, who began to chew the product to clean his teeth.The reporter stated that they were not sure if this was often, but when she saw him doing this, she told him he shouldn't be doing this.The reporter indicated that at the time she didn't think of the great danger, or she would have been more aggressive in her instruction, as she now knows the corrosive nature of this product.She stated that she truly believed it caused corrosion in his upper gi tract from where he had internal bleeding.She reported that he ended up passing away before a blood transfusion could be done.The reporter stated to please put a large warning not to chew or swallow this product because of its corrosive ingredients, so seniors or their care givers would be sure to notice and definitely be aware.Follow up information received on 19-apr-2017 (qa report received): the reporter stated: "i am unable to determine the cause or substantiate this claim." follow up received on 01 may 2017, 18 may 2017 and 19 may 2017.The male patient who received double salt denture cleanser (polident overnight denture cleanser tablets) tablet for dental cleaning.The patient died on (b)(6) 2016.The reported cause of death was gastrointestinal bleeding.Co suspects included exact denture cleanser lot number 6215065 and expiry date aug 2019.Information received via phone on 01 may 2017 : the reporter stated that she just wanted to advise to have a larger warning on the box of polident overnight tablets as that was the one the person used.The consumer did not have the box to provide the lot number and expiry date.Information received via letter on 18 may 2017 : the reporter stated that the consumer was deceased as of (b)(6) 2016.The reporter stated that she was his daughter and that he used "exact denture cleanser" lot 6215065 exp aug 2019 and stated that it was the generic brand of polident.She reported that the doctor was examining patient but his condition was not diagnosed at the time of his death.Exact denture cleanser" is not a generic brand of polident - qa confirmed lot number is not associated with a polident product.Information received on 19 may 2017 from the reporter: the reporter stated that the suspect product was the generic brand, and not polident.The consumer confirmed the product was exact denture cleanser which is not a gsk product (consumer thought it was a generic brand of polident.The patient did not receive the suspect gsk product so the case is for deletion.Comment: *downgrade report*.

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6504546
• MDR Text Key: 73180089
• Report Number: 1020379-2017-00032
• 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,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2017

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?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/01/2017; 05/24/2017
• 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): Death; Other