MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 5 MINUTE TABLETS; DENTURE CLEANSER

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Report # 1020379-2016-00066 is associated with (b)(4), polident 5 minute tablets.

Event Description

Death nos [unknown cause of death].Case description: this case was reported by a consumer via call center representative and described the occurrence of unknown cause of death in a female patient who received double salt denture cleanser (polident 5 minute tablets) effervescent tablet for product used for unknown indication.On an unknown date, the patient started polident 5 minute tablets at an unknown dose and frequency.On an unknown date, unknown after starting polident 5 minute tablets, the patient experienced unknown cause of death (serious criteria death and gsk medically significant).On an unknown date, the outcome of the unknown cause of death was fatal.The reported cause of death was unknown.It was unknown if the reporter considered the unknown cause of death to be related to polident 5 minute tablets.Additional information: this case was reported from a consumer's daughter via call centre representative on 15 november 2016.A female consumer of unknown age passed away recently.There are remaining unused polident 5 minute tablet which was bought before.And the reporter requested a refund for the unopened product.The reporter was guided that the refund is not possible from headquarter and that she could make an inquiry to a pharmacist regarding refund for the above reason.She was also guided that the headquarter cannot give a definite answer.The reporter was extremely unsatisfied with the guides given and she asserted that she should get a 100% refund.The reporter did not mention at all about the causality of the product with the adverse event.The reporter's purpose of contact was getting a refund.

Manufacturer Narrative

This report is associated with argus case (b)(4), polident 5 minute tablets.

Event Description

Worsening of kidney system [renal disease].Water in lung [lung disorder].Case description: this case was reported by a consumer via call center representative and described the occurrence of unknown cause of death in a female patient who received double salt denture cleanser (polident 5 minute tablets) effervescent tablet for product used for unknown indication.On an unknown date, the patient started polident 5 minute tablets at an unknown dose and frequency.On an unknown date, unknown after starting polident 5 minute tablets, the patient experienced unknown cause of death (serious criteria death and gsk medically significant).On an unknown date, the outcome of the unknown cause of death was fatal.The reported cause of death was unknown.It was unknown if the reporter considered the unknown cause of death to be related to polident 5 minute tablets.Additional information: this case was reported from a consumer's daughter via call centre representative on 15 november 2016.A female consumer of unknown age passed away recently.There are remaining unused polident 5 minute tablet which was bought before.And the reporter requested a refund for the unopened product.The reporter was guided that the refund is not possible from headquarter and that she could make an inquiry to a pharmacist regarding refund for the above reason.She was also guided that the headquarter cannot give a definite answer.The reporter was extremely unsatisfied with the guides given and she asserted that she should get a 100% refund.The reporter did not mention at all about the causality of the product with the adverse event.The reporter's purpose of contact was getting a refund.Follow-up information received on 24 november 2016: the patient was (b)(6).The patient recently bought 2 packs of polident 5 minute tablets but did not use them all.The consumer had diabetes and edema in lung, which caused her death.Due to worsening of the edema in the lung, the consumer stayed in the intensive care unit for 4 to 5 days.The patient died on an unspecified date.The reporter was told by a physician that the consumer passed away due to "worsening of the kidney system caused by diabetes" and that out of 5 stages of worsening of kidney system the patient was at the final stage.It was reported that water filled up the patient's lung.

• Brand Name: POLIDENT 5 MINUTE 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: 6122117
• MDR Text Key: 60744349
• Report Number: 1020379-2016-00066
• 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
• Report Date: 11/15/2016

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: 11/15/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2016
• 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): Death; Other
• Patient Age: 89 YR