MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA SUPER MOCNY MOCNO MIETOWY; DENTURE ADHESIVE

Lot Number X22D

Device Problem Product Quality Problem (1506)

Patient Problem Sore Throat (2396)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

I swallow it.[accidental device ingestion].Sore throat [sore throat].Being possibly allergic to it [device allergy].Case description: this case was reported by a consumer via call center representative and described the occurrence of sore throat in a female patient who received double salt dental adhesive cream (corega super mocny mocno mietowy) cream (batch number x22d, expiry date 31st may 2022) for denture wearer.This case was associated with a product complaint.On an unknown date, the patient started corega super mocny mocno mietowy.On an unknown date, an unknown time after starting corega super mocny mocno mietowy, the patient experienced sore throat, accidental device ingestion (serious criteria gsk medically significant), device allergy and product complaint.The action taken with corega super mocny mocno mietowy was unknown.On an unknown date, the outcome of the sore throat, accidental device ingestion, device allergy and product complaint were unknown.It was unknown if the reporter considered the sore throat, accidental device ingestion and device allergy to be related to corega super mocny mocno mietowy.When the patient removed her dentures, the adhesive was completely gone, it simply dissolved.It did not hold at all and she swallowed it.It was not even about she being possibly allergic to it because she had a mildly sore throat.Although she was not sure if it was because of the product, but the point was that the corega product did not hold at all, even though it mentioned as 'extra strong'.She already tried three times.She did not know, she might done something wrong, but it was still the same.She did not feel any mint at all.It melted and then it was completely gone.She used an adhesive which made it difficult for her to take it off because it stretched like gum.It was not on the dentures at all, as if she had swallowed it.She used it in three places.On the sides and in the middle.She went to the pharmacy but the pharmacist did not do anything and told her to call.She thought the product was useless.Case correction for the information received on 27 feb 2020.The patient initials were removed as uu referred to unknown.Follow up information received from qa department on 16 mar 2020: follow up information was received from quality assurance (qa) department regarding complaint (b)(4).The investigation reports concluded that, complaint stands unsubstantiated.Reporter stated that there were no issues noted during the manufacture of this batch as per the defect of this complaint received on an unknown date, the patient started corega super mocny mocno mietowy.On an unknown date, an unknown time after starting corega super mocny mocno mietowy, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant ).

• Brand Name: COREGA SUPER MOCNY MOCNO MIETOWY
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan; waterford, ; EI
• Manufacturer Contact: po box 13398; research triangle park,; nc ; 8255249
• MDR Report Key: 9902654
• MDR Text Key: 196777735
• Report Number: 3003721894-2020-00071
• Device Sequence Number: 1
• Product Code: KOT
• 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: 02/27/2020

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: No Information
• Device Expiration Date: 05/31/2022
• Device Lot Number: X22D
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: No
• 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