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

Device Problem Human-Device Interface Problem (2949)

Patient Problems Foreign Body In Patient (2687); Cancer (3262)

Event Type  Other  

Event Description

Kidney cancer [renal cancer].Case description: this case was reported by a consumer and described the occurrence of renal cancer in a male patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.Concurrent medical conditions included blind.On an unknown date, the patient started polident denture cleanser tablets.On an unknown date, an unknown time after starting polident denture cleanser tablets, the patient experienced renal cancer (serious criteria gsk medically significant).The action taken with polident denture cleanser tablets was unknown (dechallenge was unknown).On an unknown date, the outcome of the renal cancer was unknown.The reporter considered the renal cancer to be possibly related to polident denture cleanser tablets.Additional information: adverse event information was received on 06 october 2015.A wife that reported years ago her husband had kidney cancer and she was wondering if this was related to the use of the product since her husband did not rinse his dentures carefully enough since he is blind.No further information was provided.

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer (Section G): GSK
• Manufacturer Contact: glaxosmithkline ; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5180471
• MDR Text Key: 30122723
• Report Number: 1020379-2015-00015
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/06/2015

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 10/06/2015
• Initial Date FDA Received: 10/21/2015
• 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): Other