MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD ULTRA COREGA CREAM WITHOUT FLAVOUR; DENTURE ADHESIVE

Lot Number F69N

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Anaphylactic Shock (1703)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Anaphylactic shock [anaphylactic shock], her throat swelled [throat swelling], she got very sick [sickness], her lips swelled [lip swelling], difficulty to breathe/ she couldn't breathe [difficulty breathing], swollen tongue [swollen tongue], her throat closed [throat constriction], tonsils became inflamed [tonsillar inflammation], lip inflammation [inflammation lips], tongue inflammation [tongue inflammation].Case description: this case was reported by a physician via sales rep and described the occurrence of throat swelling in a female patient who received gsk denture adhesive (formulation unknown) (corega denture adhesive formulation unknown) unknown for product used for unknown indication.On an unknown date, the patient started corega denture adhesive formulation unknown.On an unknown date, an unknown time after starting corega denture adhesive formulation unknown, the patient experienced throat swelling and sickness.The action taken with corega denture adhesive formulation unknown was unknown.On an unknown date, the outcome of the throat swelling and sickness were unknown.It was unknown if the reporter considered the throat swelling and sickness to be related to corega denture adhesive formulation unknown.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: adverse event information was received from the medical representative via email on (b)(6) 2020.The doctor reported of a female patient who experienced swelling of throat and made her very sick when using corega adhesive.Follow up was received on 22 dec 2020, this case was reported by a physician via sales rep and described the occurrence of anaphylactic shock in a (b)(6) year-old female patient who received double salt dental adhesive cream (ultra corega cream without flavour) cream (batch number f69n, expiry date february 2021) for denture wearer.Concurrent medical conditions included drug allergy ((paracetamol or ibuprofen, one of both)).Concomitant products included no therapy.In (b)(6) 2020, the patient started ultra corega cream without flavour.On an unknown date, an unknown time after starting ultra corega cream without flavour, the patient experienced anaphylactic shock (serious criteria gsk medically significant), throat swelling, sickness, lip swelling, difficulty breathing, swollen tongue, throat constriction, tonsillar inflammation, inflammation lips and tongue inflammation.The patient was treated with betamethasone (celestone).On an unknown date, the outcome of the anaphylactic shock, throat swelling, sickness, lip swelling, difficulty breathing, swollen tongue, throat constriction, tonsillar inflammation, inflammation lips and tongue inflammation were unknown.It was unknown if the reporter considered the anaphylactic shock, throat swelling, sickness, lip swelling, difficulty breathing, swollen tongue, throat constriction, tonsillar inflammation, inflammation lips and tongue inflammation to be related to ultra corega cream without flavour.This report is made by gsk without prejudice and does not imply any admission o r liability for the incident or its consequences.The patient was not diabetic, not hypertense.She was a healthy patient.Physician reported she made a set of dentures on the upper and lower patien because she rotated the jaw when chewing and needed an adhesive.Physician referred that she applied 5 minimum drops on the denture.Patient route of administration was oral.Patient was healthy from her gums, did not bother anything even though her denture moved a lot.She needed an adhesive.Her lips got inflamed, the upper covered her nose did not let her breath and lower reached the chain.Her tongue got inflamed that it did not fit in her mouth and closed her throat.Tonsils got inflamed that she could not breath.Physician referred that her family member had to take her to a particular doctor who injected her and indicated that she had anaphylactic shock.This report is being resubmitted to capture corrections.The information was received on 22 dec 2020 and is as follows.Device medwatch information form was filled (previously missed to fill).

• Brand Name: ULTRA COREGA CREAM WITHOUT FLAVOUR
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 11154784
• MDR Text Key: 230459237
• Report Number: 3003721894-2020-00389
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 12/14/2020

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?: No
• Device Operator: Lay User/Patient
• Device Lot Number: F69N
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/12/2021
• 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): Other
• Patient Age: 72 YR