MAUDE Adverse Event Report: BLOCK DRUG CO., INC. COREGA TABS 3 MINUTEN; DENTURE CLEANSER

Lot Number EF5Y

Device Problem Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Worried that product intoxicated her [drug intolerance].Case description: this case was reported by a consumer via call center representative and described the occurrence of drug intolerance in a female patient who received denture cleanser (corega tabs 3 minuten) tablet (batch number ef5y, expiry date 28th february 2021) for drug use for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started corega tabs 3 minuten.On an unknown date, an unknown time after starting corega tabs 3 minuten, the patient experienced drug intolerance (serious criteria gsk medically significant) and product complaint.The action taken with corega tabs 3 minuten was unknown.On an unknown date, the outcome of the drug intolerance and product complaint were unknown.It was unknown if the reporter considered the drug intolerance to be related to corega tabs 3 minuten.Additional details: patient bought some corega cleaning tabs, they was rotten.First of all, the packaging was like swollen and second of all, she tried one.She use them constantly.When she put the tab in the cup it didn´t effervesce.It has a weird smell and color.The package was a really strange thing.She was worried that it might have intoxicated her because that cup was where she put the dentures in.

Event Description

Worried that product intoxicated her [adverse reaction].Case description: this case was reported by a consumer via call center representative and described the occurrence of drug intolerance in a female patient who received denture cleanser (corega tabs 3 minuten) tablet (batch number ef5y, expiry date 28th february 2021) for drug use for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started corega tabs 3 minuten.On an unknown date, an unknown time after starting corega tabs 3 minuten, the patient experienced drug intolerance (serious criteria gsk medically significant) and product complaint.The action taken with corega tabs 3 minuten was unknown.On an unknown date, the outcome of the drug intolerance and product complaint were unknown.It was unknown if the reporter considered the drug intolerance to be related to corega tabs 3 minuten.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: patient bought some corega cleaning tabs, they was rotten.First of all, the packaging was like swollen and second of all, she tried one.She use them constantly.When she put the tab in the cup it didn´t effervesce.It has a weird smell and color.The package was a really strange thing.She was worried that it might have intoxicated her because that cup was where she put the dentures in.This report is being resubmitted to capture corrections.The information was received on 04 jul 2019 and is as follows: the event drug intolerance was re coded as adverse reaction.Follow up was received from quality assurance department on 28 oct 2019: the deviation report from trackwise entered as an attachment.Quality assurance analysis revealed the product complaint to be substantiated.Follow up was received from quality assurance department on 10 oct 2019: a potential cause for the deviation was exposure to prolonged periods of time to high temperatures.Exposure to high temperatures for extended periods of time posed the risk of activating the product, thus caused the tablet pouches to inflate or puff up.The root cause of the deviation had not determined.At the point the product left the memphis site, that was in a good condition.Evidence of temperature excursions during transport cannot be determined as temperature monitoring devices (temp tales) were not placed on the shipments per applicable technical terms of supply.Quality assurance analysis revealed the product complaint to be substantiated.Downgrade report.

Manufacturer Narrative

Argus case (b)(4).Product complaint investigation received on 10 october 2019 : monthly consumer complaint trending for the month of july 2019 identified lot trends for quick cleaning polident/corega with triplemint lot ef 5y / sku la66139 for season code cpa dmg/def, "other packaging issues" and cpa dmg/def prim, "primary packaging is damaged to defective ".The complaint reason threshold of no more than ten (10) and eight (8) complaints, respectively, against a lot for these specific defects was exceeded.The verbatim of the complaint issues were reviewed and the common theme of the complaints reported inflated pouches.The batch documentation for lot ef5y was reviewed.It showed no evidence of failures during production in-process checks/test or deviations.Retain samples were examined.All samples were in an acceptable state with no evidence of puffed/inflated pouches.Per the shipping documentation, the product was shipped on 06 and 07-may-2019 in 5 shipments; 4 via air and 1 via sea freight.None the shipments used climate controlled container, and temperature monitoring devices/temp tales were not placed on any of the shipments.Per technical terms of supply mem-arg-01, section a.1 responsibilities not covered by default arrangements, ref 1.27."gsk ch is responsible for the product from the point it departs the gsk memphis warehouse ".The root cause of this deviation could not be determined.At the point the product left the memphis site, it was in a good condition and complied with the relevant packaging and finished product specifications.Evidence of exposure to high temperatures during transport cannot be determined as temperature monitoring devices (temp tales) were not placed on the shipments as required by the applicable technical terms of supply.Appropriate preventive actions were put in place per capa 933130 to ensure temp tale requirements are met.The actions outlined in this capa went into effect in 06-may-2019, after the product was shipped.

• Brand Name: COREGA TABS 3 MINUTEN
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 8798319
• MDR Text Key: 151312978
• Report Number: 1020379-2019-00039
• 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,Followup
• Report Date: 07/04/2019

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
• Device Expiration Date: 02/28/2021
• Device Lot Number: EF5Y
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 10/10/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other