MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA SIN SABOR (WITHOUT FLAVOUR); DENTURE ADHESIVE

Lot Number DE9610 1

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Diarrhea (1811); Inflammation (1932); Vomiting (2144); Malaise (2359)

Event Type  Injury  

Manufacturer Narrative

Mfr report is associated with argus case (b)(4), corega sin sabor (without flavor).Corega sin sabor is marketed as super poligrip in the us.

Event Description

Liver inflammation [liver inflammation].Vomiting [vomiting].Diarrhea [diarrhea].Intense malaise [malaise].Case description: this case was reported by a consumer via call center representative and described the occurrence of liver inflammation in a (b)(6) female patient who received double salt dental adhesive cream (corega sin sabor (without flavour)) cream (batch number d 9610 1, expiry date may 2021) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started corega sin sabor (without flavour) at an unknown dose and frequency.On an unknown date, an unknown time after starting corega sin sabor (without flavour), the patient experienced liver inflammation (serious criteria gsk medically significant), vomiting, diarrhea, malaise and product complaint.The patient was treated with pargeverine hydrochloride (sertal).Corega sin sabor (without flavour) was discontinued on (b)(6) 2019 (dechallenge was negative).On an unknown date, the outcome of the liver inflammation was not recovered/not resolved and the outcome of the vomiting, diarrhea, malaise and product complaint were unknown.It was unknown if the reporter considered the liver inflammation, vomiting, diarrhea and malaise to be related to corega sin sabor (without flavour).Additional details: the consumer had been used corega sin sabor (without flavor).The product presents with a quality issue (she stated that it had an unpleasant smell) and she presented with intense malaise referred as vomiting, diarrhea and liver inflammation.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of liver inflammation in a 61-year-old female patient who received double salt dental adhesive cream (corega sin sabor (without flavour)) cream (batch number: d 9610 1, expiry date may 2021) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started corega sin sabor (without flavour) at an unknown dose and frequency.On an unknown date, an unknown time after starting corega sin sabor (without flavour), the patient experienced liver inflammation (serious criteria gsk medically significant), vomiting, diarrhea, malaise and product complaint.The patient was treated with pargeverine hydrochloride (sertal).Corega sin sabor (without flavour) was discontinued on (b)(6) 2019 (dechallenge was negative).On an unknown date, the outcome of the liver inflammation was not recovered/not resolved and the outcome of the vomiting, diarrhea, malaise and product complaint were unknown.It was unknown if the reporter considered the liver inflammation, vomiting, diarrhea and malaise to be related to corega sin sabor (without flavour).Additional details; the consumer had been used corega sin sabor (without flavor).The product presents with a quality issue (she stated that it had an unpleasant smell) and she presented with intense malaise referred as vomiting, diarrhea and liver inflammation.Follow up information was received from quality assurance department on 01 feb 2019: this case was reported in patient who received double salt dental adhesive cream (corega sin sabor (without flavour)) cream (batch number: de9610 1, expiry date 31st may 2021).The quality analysis reveled that the complaint was unsubstantiated.Batch number and expiry date updated.

Manufacturer Narrative

Argus case: (b)(4), corega sin sabor (without flavor).Corega sin sabor is marketed as super poligrip in the us.On 01 february 2019, the qa department performed the complaint closure for issue (b)(4).The complaint will be closed as unsubstantiated.Upon the receipt of the sample, the batch number and the expiration date of product were verified and the correct ones are de9610 1 and 31-may-2021.

• Brand Name: COREGA SIN SABOR (WITHOUT FLAVOUR)
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 8267367
• MDR Text Key: 133976770
• Report Number: 3003721894-2019-00018
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

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: 05/31/2021
• Device Lot Number: DE9610 1
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 01/22/2019
• Supplement Dates Manufacturer Received: 02/01/2019
• Supplement Dates FDA Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 75