MAUDE Adverse Event Report: POLIDENT TOTAL ACTION CLEANER; DENTURE CLEANSER

Lot Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Veeva case: (b)(4).
Event or Problem Description
Swallowed a glass in which she had put her polident tablet [accidental device ingestion] colic and stomach pain [colic] dry gums [gum pain] stomach ache [stomach ache] case description: on 2024-08-14 a spontaneous case was reported in france by a pharmacist via other manual source.The report concerns a 88 year old elderly female consumer.The consumer received polident total action cleaner (napc+potm+taed tablet) on (b)(6) 2024 for indication drug use for unknown indication.Batch number and expiry was not reported.No concomitant medications were reported.On (b)(6) 2024, within 2 days after starting polident total action cleaner,the consumer experienced a serious medically significant swallowed a glass in which she had put her polident tablet (accidental device ingestion).The outcome of the event swallowed a glass in which she had put her polident tablet (accidental device ingestion) was unknown.On an unknown date, the consumer experienced a non-serious stomach ache, dry gums and colic and stomach pain, (preferred term: abdominal pain upper, gingival pain, and abdominal pain).The outcome of the event stomach ache, dry gums, and colic and stomach pain (abdominal pain upper, gingival pain, and abdominal pain) was unknown.The consumer's relevant medical history includes: cardiovascular diseases (not ongoing), osteoporosis (not ongoing), and osteoarthrosis (not ongoing), no drug history was reported.The action taken with polident total action cleaner was unknown.Dechallenge was unknown and rechallenge was not applicable for the events accidental device ingestion, abdominal pain upper, gingival pain, and abdominal pain.The causality of the events accidental device ingestion, abdominal pain upper, gingival pain, and abdominal pain was reported as not reported / not assessable.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.The reporter provided the following comment: "i'll give you the phone number pi so i can't contact you by phone phone my request is as follows.I have a patient, a pi year old lady who unfortunately, a week ago, swallowed a glass in which she had put her polident tablet.----- outbound call 2024-04-14 ----- the person is not here, she will be here next week.----- new info received in related case (b)(4) on 2024-08-14 -------from: pisent: wednesday, 2024-08-14 2:15 pmto: pi; pi; pi; pi; picc: pisubject: tr: transmission of a pharmacovigilance notification 2024-cst-np-mng-0095hello,please find attached a pharmacovigilance notification:polident nettoyant total action we received a call from the val vert pharmacy reporting a pharmacovigilance case: a customer came after swallowing polident nettoyage total action liquid with water.She observed the following symptoms: colic and stomach pain last week, as well as dry gums today., regarding your laboratory.Kind regards, pitechnician quality assurancepipistandard: pitel: pi----- new info received internally in related case (b)(4) on 2024-08-16 ----dear all,please find below the first information i managed to get on the case by calling the pharmacy.Patient:initial s: piage: pi years-oldmedical history: has treatments for cardiovascular diseases, osteoporosis, osteoarthrosis, she also takes pain relief and antidepressants.Event:date: the patient ingested the product around the 2024-08-07 but she didn't tell her pharmacist until a week later (on the 2024-08-14).When did the symptoms appear: the symptoms appeared around 24 hours after the ingestion.Product familiarity: she was used to the product, but she probably put a glass with the product next to a glass of water she wanted to drink, and drank the wrong glass.Reporter:pharmacy:: piaddress:piphone number: pireporter: piproduct:name: polident total action cleanserbatch:?expiry date:?is the product still available:?kind regards,piqa pharmacisthaleon francepipiemail: pi".

• Brand Name: POLIDENT TOTAL ACTION CLEANER
• Common Device Name: DENTURE CLEANSER
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059
• MDR Report Key: 20062515
• Report Number: 1314819-2024-00072
• Device Sequence Number: 7401805
• Product Code: EFT
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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
• Operator of Device: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/26/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR
• Patient Sex: Female