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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Death (1802); Peeling (1999); Skin Erosion (2075)

Event Type  Death  

Manufacturer Narrative

Report 1020379-2018-00009 is associated with (b)(4), polident 5 minute cleaning tablet.

Event Description

Death nos [unknown cause of death], skin rough on two fingers [skin rough], skin peeling on two fingers [skin peeling].Case description: this case was reported by a consumer via call center representative and described the occurrence of death nos in a male patient who received double salt denture cleanser (polident 5 minute cleaning tablet) effervescent tablet for product used for unknown indication.On an unknown date, the patient started polident 5 minute cleaning tablet at an unknown dose and frequency.On an unknown date, an unknown time after starting polident 5 minute cleaning tablet, the patient experienced death nos (serious criteria death and gsk medically significant), skin rough and skin peeling.The action taken with polident 5 minute cleaning tablet was unknown.On an unknown date, the outcome of the death nos was fatal and the outcome of the skin rough and skin peeling were not reported.The reported cause of death was unknown cause of death.It was unknown if the reporter considered the death nos, skin rough and skin peeling to be related to polident 5 minute cleaning tablet.Additional details: reporter stated that a male consumer of unknown age picked his denture out by his hand and rinsed off his denture after he soaked his denture with polident 5 minute cleaning tablet in water.His skin got rough and peeled on two fingers he used when he picked his denture out.So, he guided the reporter not to pick a denture out by hands.It was not confirmed about hcp consultation.It was confirmed that he passed away.The cause of death was not mentioned by reporter.(b)(4).

• Brand Name: POLIDENT 5 MINUTE CLEANING TABLET
• 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: 7241845
• MDR Text Key: 99041501
• Report Number: 1020379-2018-00009
• 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
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/05/2018
• 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