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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Rash (2033); Tissue Damage (2104); Burning Sensation (2146); Caustic/Chemical Burns (2549)

Event Type  Other  

Event Description

Chemical burn on her tongue [chemical burn of oral cavity].Mouth blistering [blistering of mouth].Mouth rash [rash mouth].Mouth burning [burning mouth].Red mouth [oral redness].Tongue red [tongue redness].Product complaint [product complaint].Case description: this case was reported by a consumer and described the occurrence of blister of mouth in a (b)(6) female patient who received double salt denture cleanser (polident overnight denture cleanser tablets) tablet for denture wearer.On an unknown date, the patient started polident overnight denture cleanser tablets.On (b)(6) 2015, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced blistering of mouth, rash mouth, burning mouth, oral redness and tongue redness.On an unknown date, the patient experienced product complaint.Polident overnight denture cleanser tablets was discontinued (dechallenge was negative).On an unknown date, the outcome of the blistering of mouth, rash mouth, burning mouth, oral redness and tongue redness were not recovered/not resolved and the outcome of the product complaint was unknown.

Manufacturer Narrative

The reporter considered the blistering of mouth, rash mouth, oral redness and tongue redness to be related to polident overnight denture cleanser tablets.Additional details: on (b)(6) 2015, the consumer reported she has been using polident overnight whitening tablets for a year and a half, and she started using the tablets of this particular box about 5 to 6 days ago, and the symptoms appeared yesterday ((b)(6) 2015).The events are still ongoing.A product complaint is also reported as the consumer thinks that there must be something with this particular box that has caused the reported events.Adverse event (ae) revision note received on 26 may 2015.Consumer reported when using polident overnight whitening that she had a chemical burn on her tongue which she further explained that if felt like a chemical burn.The consumer described her use of polident overnight whitening for over a year and never had any issues.She was using fixodent but feels there was something with the particular lot.The reporter considered the chemical burn of oral cavity to be related to polident overnight denture cleanser tablets.

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: p.o. box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 4908310
• MDR Text Key: 6025948
• Report Number: 1020379-2015-00009
• 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: 05/20/2015

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 07/09/2015
• 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
• Treatment: FIXODENT (CARMELLOSE SODIUM + POLYVINYL ALCOHOL)
• Patient Outcome(s): Other
• Patient Age: 48 YR