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

Lot Number MF061713B

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Caustic/Chemical Burns (2549); Partial thickness (Second Degree) Burn (2694)

Event Date 10/08/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Skin in his mouth is burned [chemical burn of oral cavity], mouth started burning [burning mouth], skin in the back of his mouth is blistered [blistering of mouth].Case description: this case was reported by a consumer and described the occurrence of chemical burn of oral cavity in a male patient who received double salt denture cleanser (polident overnight denture cleanser tablets) tablet (batch number mf061713b, expiry date unknown) for dental care and device color issue.On an unknown date, the patient started polident overnight denture cleanser tablets.On (b)(6) 2017, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced chemical burn of oral cavity (serious criteria gsk medically significant), burning mouth and wrong technique in device usage process.On (b)(6) 2017, the patient experienced blistering of mouth.The action taken with polident overnight denture cleanser tablets was unknown.On an unknown date, the outcome of the chemical burn of oral cavity, burning mouth, blistering of mouth and wrong technique in device usage process were unknown.It was unknown if the reporter considered the chemical burn of oral cavity, burning mouth and blistering of mouth to be related to polident overnight denture cleanser tablets.Additional details: the patient reported that he has had dentures for two years.He was using the overnight polident and failed to rinse off before placing the dentures back in his mouth (wrong technique in device usage process).He left his house and his mouth started burning (burning mouth).He went to the nearest fire station and they said he burned the skin on his mouth (chemical burn of oral cavity).Two days later he realized the skin in the back of his mouth is blistered (blistering of mouth).He planned to see his healthcare provider the day of the call.

• 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: 6950769
• MDR Text Key: 89380617
• Report Number: 1020379-2017-00071
• 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
• Type of Report: Initial
• Report Date: 10/10/2017

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: Lay User/Patient
• Device Lot Number: MF061713B
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/16/2017
• 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): Other