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

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

This report is associated with argus case (b)(4), polident overnight denture cleanser tablets.

Event Description

Passed away [death].Case description: this case was reported by a consumer via call center representative and described the occurrence of death in a female patient who received double salt denture cleanser (polident overnight denture cleanser tablets) tablet for product used for unknown indication.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 death (serious criteria death and gsk medically significant).On an unknown date, the outcome of the death was fatal.The reported cause of death was death.It was unknown if the reporter considered the death to be related to polident overnight denture cleanser tablets.Additional details, report received from consumer's husband.The consumer's husband reported that he found old polident overnight and wanted to knew if he could still use the product.He mentioned that the product was for his wife who passed away two years ago.

Manufacturer Narrative

This report is associated with argus case (b)(4), polident overnight denture cleanser tablets.Qa investigation was conducted even though a product complaint event was not reported.No sample was received and no lot number given; therefore, the qa department was unable to complete a full investigation.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of death in a female patient who received double salt denture cleanser (polident overnight denture cleanser tablets) tablet for product used for unknown indication.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 death (serious criteria death and gsk medically significant).On an unknown date, the outcome of the death was fatal.The reported cause of death was death.It was unknown if the reporter considered the death to be related to polident overnight denture cleanser tablets.Additional details, report received from consumer's husband.The consumer's husband reported that he found old polident overnight and wanted to knew if he could still use the product.He mentioned that the product was for his wife who passed away two years ago.Follow up information received 03 january 2017 please note: for regulatory reporting purposes a qa investigation was conducted even though a product complaint event was not reported.No sample received and no lot number given.Also, there isn't any details given as to what the incident was.The qa department was therefore unable to investigate fully.

• 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: 6195933
• MDR Text Key: 63021097
• Report Number: 1020379-2016-00073
• 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: 12/14/2016

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: Lay User/Patient
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: No
• 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