MAUDE Adverse Event Report: BLOCK DRUG CO., INC. COREGA DENTAL WHITE TABLET; DENTURE CLEANSER

Lot Number DW5G

Device Problem Use of Device Problem (1670)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

1020379-2016-00003 is associated with argus case (b)(4) corega dental white tablet.Corega dental white tablets are marketed as polident tablets in the us.

Event Description

Itching [pruritus], rash [rash], allergy [allergy].Accidental device ingestion [accidental device ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of pruritus in a (b)(6) female patient who received corega dental white tablet tablet (batch number (b)(4), expiry date 20th april 2018) for product used for unknown indication.Concurrent medical conditions included alzheimer's disease.In (b)(6) 2015, the patient started corega dental white tablet.In (b)(6) 2015, less than a year after starting corega dental white tablet, the patient experienced pruritus (serious criteria hospitalization), rash (serious criteria hospitalization) and allergy (serious criteria hospitalization).On an unknown date, the patient experienced accidental device ingestion (serious criteria hospitalization and gsk medically significant).On an unknown date, the outcome of the pruritus, rash and allergy were recovering/resolving and the outcome of the accidental device ingestion was unknown.The reporter considered the pruritus, rash and allergy to be possibly related to corega dental white tablet.It was unknown if the reporter considered the accidental device ingestion to be related to corega dental white tablet.Additional details: the reporter is the patient sister.The patient was using the product sometime in (b)(6) 2015 and in (b)(6) 2015 started having the itching, rash and allergy.She was admitted to hospital in (b)(6) 2015 and treated for the above mentioned conditions.The reporter did not know the diagnosis and the exact treatment that was prescribed following hospitalization.She mentioned that the consumer was prescribed with a solution to apply on the skin, seretide and sulfur soap.After this the consumer consulted and allergologist who could not find an explanation for the itching, rash and allergy.In (b)(6) 2016 the itching, rash and allergy reoccurred and the consumer was directed to the same hospital but this time the attending doctor did not consider that hospitalization was necessary and prescribed ambulatory treatment.The reported did not know what treatment was prescribed.The reporter mentioned that due to alzheimer condition communication with the consumer was very difficult.The reporter found out recently that the consumer was not taking the corega tabs as explained but she was ingesting them.The consumer did not know when the tablets were ingested but she assumed that the consumer could only ingest a few, maybe 6, as this was how many the consumer had available.The reporter thus thought that the itching, rash and allergy might be due to the fact that the consumer ingested the tablets.The reporter said that she would address this information to a doctor and ask medical opinion related to this fact.The action taken with the suspect product was withdrawn.Dechallenge was positive and rechallenge was not applicable.

• Brand Name: COREGA DENTAL WHITE TABLET
• 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: 5529815
• MDR Text Key: 41312819
• Report Number: 1020379-2016-00003
• 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,foreign
• Type of Report: Initial
• Report Date: 03/17/2016

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 Expiration Date: 04/20/2018
• Device Lot Number: DW5G
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 03/28/2016
• 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): Hospitalization; Other
• Patient Age: 79 YR