MAUDE Adverse Event Report: BLOCK DRUG CO. INC. POLIDENT DENTURE CLEANSER OVERNIGHT WHITENING; CLEANSER, DENTURE, OVER THE COUNTER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Pain (1994); Swelling (2091); Burning Sensation (2146); Complaint, Ill-Defined (2331)

Event Date 05/08/2018

Event Type  Injury  

Event Description

I had soaked my dentures in polident overnight whitening cleaner.At 7 am i cleaned my dentures with a brush then rinsed each plate for at least 2 minutes.I put my dentures in and went on about my morning.I had noticed that my gums felt tingly.Around 10 am i decided to take my dentures out and rinse my mouth.I noticed there were sores on my gums where it looked like my skin had been burned, my gums were swollen and very tender, my stomach hurt and i have felt sluggish since i removed my dentures.I immediately rinsed my mouth and washed my denture bath.I was recommended by my dentist to discontinue use, watch for any other side effects, leave my dentures out so my gums can heal, rest and drink lots of fluid, and call if i need to.

• Brand Name: POLIDENT DENTURE CLEANSER OVERNIGHT WHITENING
• Type of Device: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): BLOCK DRUG CO. INC.
• MDR Report Key: 7510782
• MDR Text Key: 108263210
• Report Number: MW5077188
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/09/2018

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: No Information
• Other Device ID Number: 310158034407
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 77