MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 3 MINUTE; DENTURE CLEANSER

Lot Number W26F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Had some bleeding rectally [rectal bleeding].I only had a little bit go in my mouth [accidental device ingestion].My urine had little tiny pieces when it came out [urine abnormality].My lips have little bubbles [lip blister].I went out and by the end of the day my eyes got bad and i couldn't see [visual impairment].She found a hole in my ear [ear injury].I don't think that did it because i had a pretty bad fall [fall].I got the toothbrush that i use to clean the teeth in my mouth [wrong technique in device usage process].Case description: this case was reported by a consumer and described the occurrence of rectal bleeding in a (b)(6) year old female patient who received denture cleanser (polident 3 minute) tablet (batch number w26f, expiry date 28th february 2022) for dental cleaning.On an unknown date, the patient started polident 3 minute.On an unknown date, an unknown time after starting polident 3 minute, the patient experienced rectal bleeding (serious criteria gsk medically significant), accidental device ingestion (serious criteria gsk medically significant), urine abnormality, lip blister, visual impairment, ear injury, fall and wrong technique in device usage process.The patient was treated with vaseline.The action taken with polident 3 minute was unknown.On an unknown date, the outcome of the rectal bleeding, accidental device ingestion, urine abnormality, visual impairment, ear injury, fall and wrong technique in device usage process were unknown and the outcome of the lip blister was not recovered/not resolved.It was unknown if the reporter considered the rectal bleeding, accidental device ingestion, urine abnormality, lip blister, visual impairment, ear injury, fall and wrong technique in device usage process to be related to polident 3 minute.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information, adverse event information was received on 16 december 2019 via live call.Consumer reported that, "i am calling about polident, i was at the dentist and i got a tiny little new tooth.It was 11 at night and i got up in the middle of the night and realized i didn't brush my teeth and i got the toothbrush that i use to clean the teeth in my mouth.By the end of the day i couldn't see by the time i got home.It's been 2 weeks and i am still dealing with it and i have a little bit of bleeding.I only had a little bit go in my mouth, i am just trying to make sure that i don't die.I have a doctors appointment in 2 days.After i ran the water in my mouth it helped a little bit.I have two different brushes and the one i use with the polident.I had some bleeding rectally and my urine had little tiny pieces when it came out.Its no ones fault but my own.My lips have little bubbles on them and i am using vaseline.I wont say its getting worse but its not going away.It was only a little bit on my brush but it left a mark.That day after doing that i went out and by the end of the day my eyes got bad and i couldn't see, so i put water on it.I went to the doctor and i was getting my ears checked out and she found a hole in my ear and i told him what i did with the polident.I don't think that did it because i had a pretty bad fall.I just want to know what to do and what effect this will have".

• Brand Name: POLIDENT 3 MINUTE
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis,; TN
• Manufacturer Contact: po box 13398; research triangle park,; 8888255249
• MDR Report Key: 9557890
• MDR Text Key: 189437149
• Report Number: 1020379-2019-00062
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/28/2022
• Device Lot Number: W26F
• Date Manufacturer Received: 12/16/2019
• 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
• Patient Age: 92 YR