| Lot Number JG4D |
| Device Problem
Product Quality Problem (1506)
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| Patient Problem
Anaphylactic Shock (1703)
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Event Type
Injury
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Event Description
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Anaphylactic shock [anaphylactic shock], completely absorbed by my gums,sank into the gums [gingival discomfort], thought i was going to suffocate [suffocation feeling], patient reports tongue swelling and shortness of breath.[shortness of breath], patient reports tongue swelling and shortness of breath.[swollen tongue], swelling of the floor of the mouth [mouth edema], lower lip swelling [lip swelling], odontogenic foci of infection [odontogenic infection], dysphagia [dysphagia], pain [oral pain], tooth no.37 was extracted [tooth extraction].Case description: this case was reported by a consumer via call center representative and described the occurrence of gingival discomfort in a 84-year-old male patient who received double salt dental adhesive cream (corega maxseal) cream (batch number jg4d, expiry date unknown) for denture wearer.This case was associated with a product complaint.In 2023, the patient started corega maxseal.In 2023, less than 4 months after starting corega maxseal, the patient experienced gingival discomfort, suffocation feeling, shortness of breath, swollen tongue and product complaint.The action taken with corega maxseal was unknown.On an unknown date, the outcome of the gingival discomfort, suffocation feeling, shortness of breath, swollen tongue and product complaint were recovered/resolved.The reporter considered the gingival discomfort to be related to corega maxseal.It was unknown if the reporter considered the suffocation feeling, shortness of breath and swollen tongue to be related to corega maxseal.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received from consumer via call center representative (phone) on 31jul2023 and reported that "i want to ask about something.It's about corega; it is for under the teeth.I went to the pharmacy and asked this lady.I used it 2-3 times and it was completely absorbed by my gums.They gave me seven ivs at the er.She told me to discontinue this categorically.It simply absorbed everything.It was completely absorbed.I though i was going to suffocate.I will not be using this.I would like to get advice and issue a warning.The consumer does not remember when exactly he started using it or when ae happened since it was 2-3 months ago.He also does not want to send anything to us just to inform us of what happened to him after using our product".Follow up information was received from consumer via call center representative (phone) on 01aug2023 and reported that "i did not use it daily, only when i was going to see a doctor/dentist.Information from emergency services/ hospital: "patient reports tongue swelling and shortness of breath." i've decided to ship the product to you.I have been using it according to the leaflet.I had it for the first time.I have never used it before.It fell off after 3-4 hours, it sank into the gums.This is interesting.This is a warning for the company.The dentist said that the tooth had nothing to do with it and possibly it was corega, which sank into the gums".Initial and follow up processed together.Follow up information was received from consumer via email on 08aug2023.Con-current condition of arterial hypertension and depression was added.Lab data was added.Product start date 2023 was removed.Concomitant medications lokren 20, zomiren and polfenon was added.Treatment medication cetix [film-coated tablets] 0.4 g once a day, encorton [tablets] 1 mg twice a day, enterol [hard capsules] 0.25 g twice a day and lirra [film-coated tablets] 5 mg once a day was added.Additional event of anaphylactic shock (haleon medically significant event), mouth edema, odontogenic infection, lip swelling, dysphagia, pain, tooth extraction was added with unknown causality.Additional details: it was reported that "the patient reports tongue swelling and dyspnea.Dental filling inserted yesterday.Surgical consultation ordered.After the procedure, discharged in stable state with recommendations.Laboratory data included: ast (aspartate aminotransferase test) 36 u/l, ck (blood creatine phosphokinase) 126 u/l, crp (c-reactive protein) 1.0 mg/l, time 13.0 sec (normal range 11.00-17.00), prothrombin index 102% (normal range 70.00-130.00), inr (international normalized ratio) 0.97 (normal range 0.80-1.20), na (blood sodium)136 mmol/l (normal range 136-145), k (blood potassium) 4.9 mmol/l (normal range 3.5-5.1), gluc (blood glucagon) 112 mg/dl, 70-99 mg/dl normal fasting blood glucose level 100-125 mg/dl abnormal fasting blood glucose level, ogtt recommended = 126 mg/dl diabetes mellitus (after two tests in fasting condition), creatinine 1.5 mg/dl (normal range 0.8-1.4), wbc (white blood cells) 8.02 (normal range 4.00-10.00), rbc (red blood cells) 4.34 (normal range 3.90- 5.70), hgb (hemoglobin) 14.3 g/dl (normal range 12.0-17.0), hct (hematocrit) 42.4% (normal range 40.0- 54.0), mcv (mean cell volume) 97.7 fl (normal range 80.0- 96.0), mch (mean cell hemoglobin) 32.9 pg (normal range 27.0-34.0) mchc (mean cell hemoglobin concentration) 33.7 g/dl (normal range 33.0-36.0), rdw-cv () 14.3% (normal range 11.5-14.5), plt (platelet count) 150 (normal range 150-400), pdw (platelet distribution width) 11.7 fl (normal range 9.0- 17.0), mpv (mean platelet volume)10.2 fl (normal range 7.4-10.4), p-lcr (platelet-large cell ratio) 26.4% (normal range 19-47), pct (procalcitonin)0.15% (normal range 0.16-0.36), nrbc (nucleated red blood cells) 0.000.Diagnosis: swelling of the tongue and floor of the mouth on the left side.Odontogenic foci of infection.83-year-old male patient consulted by oral surgeon due to tongue swelling, which, according to the patient, developed today in the morning.Patient reports an episode of lower lip swelling on the left side, approximately 2 months ago after using denture fixative.No breathing disorders reported by the patient.Dysphagia reported.Pain reported to be at a level of 2 using nrs (0-10, where 0 is no pain).Patient with normal orientation to person, time and place.Cardiovascularly and respiratorily stable.Generic diseases: arterial hypertension, depression.Medications: lokren 20, zomiren 0.5, polfenon.Patient does not report allergies.Stimulants: denies.Extra-orally: facial symmetry maintained.Ocular motility maintained in 9 directions.Good vision.Round, symmetrical, correctly responding pupils.Patent nasal passage.Normal jaw grading: 4 cm.No pain at trigeminal pressure points.Intraorally: pink, smooth and glittering mucous membrane.Tooth no.37 visible with extensive filling and loss of hard tissues; painful in percussion test swelling of the tongue and floor of the mouth on the left side.No pus presence.Referred to opg x-ray that showed condition after root canal treatment and unfilled root canals of tooth 37.As part of oral cavity sanitation, tooth no.37 was extracted through alveolar chiseling with conduction anesthesia (2% lign+nor).During extraction process the mesial and distal root apex were broken.Curettage performed.Dressing applied.Patient was instructed.No indications for hospitalization at the department of oral and maxillofacial surgery follow up at (hospital oral and maxillofacial surgery outpatient clinic) on 21.09.2022 at 8-10:00 am or immediately in the case of deterioration of general or local status 2.Follow up opg x-ray in order to assess presence of remaining root canal apices of tooth 37.3.Cold packs on left cheek; avoid warming the treatment area 4.Standard diet 5.Avoid strenuous activity 6 increased oral hygiene 7.I suggest anti-allergic and antiedema therapy.".
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Manufacturer Narrative
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Argus case:(b)(4).
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Manufacturer Narrative
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Agus case: (b)(6).
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Event Description
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Case description: this case was reported by a consumer via call center representative and described the occurrence of gingival discomfort in a 84-year-old male patient who received double salt dental adhesive cream (corega maxseal) cream (batch number jg4d, expiry date unknown) for denture wearer.This case was associated with a product complaint.In 2023, the patient started corega maxseal.In 2023, less than 4 months after starting corega maxseal, the patient experienced gingival discomfort, suffocation feeling, shortness of breath, swollen tongue and product complaint.The action taken with corega maxseal was unknown.On an unknown date, the outcome of the gingival discomfort, suffocation feeling, shortness of breath, swollen tongue and product complaint were recovered/resolved.The reporter considered the gingival discomfort to be related to corega maxseal.It was unknown if the reporter considered the suffocation feeling, shortness of breath and swollen tongue to be related to corega maxseal.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received from consumer via call center representative (phone) on 31jul2023 and reported that "i want to ask about something.It's about corega; it is for under the teeth.I went to the pharmacy and asked this lady.I used it 2-3 times and it was completely absorbed by my gums.They gave me seven ivs at the er.She told me to discontinue this categorically.It simply absorbed everything.It was completely absorbed.I though i was going to suffocate.I will not be using this.I would like to get advice and issue a warning.The consumer does not remember when exactly he started using it or when ae happened since it was 2-3 months ago.He also does not want to send anything to us just to inform us of what happened to him after using our product".Follow up information was received from consumer via call center representative (phone) on 01aug2023 and reported that "i did not use it daily, only when i was going to see a doctor/dentist.Information from emergency services/ hospital: "patient reports tongue swelling and shortness of breath." i've decided to ship the product to you.I have been using it according to the leaflet.I had it for the first time.I have never used it before.It fell off after 3-4 hours, it sank into the gums.This is interesting.This is a warning for the company.The dentist said that the tooth had nothing to do with it and possibly it was corega, which sank into the gums".Initial and follow up processed together.Follow up information was received from consumer via email on 08aug2023.Con-current condition of arterial hypertension and depression was added.Lab data was added.Product start date 2023 was removed.Concomitant medications lokren 20, zomiren and polfenon was added.Treatment medication cetix [film-coated tablets] 0.4 g once a day, encorton [tablets] 1 mg twice a day, enterol [hard capsules] 0.25 g twice a day and lirra [film-coated tablets] 5 mg once a day was added.Additional event of anaphylactic shock (haleon medically significant event), mouth edema, odontogenic infection, lip swelling, dysphagia, pain, tooth extraction was added with unknown causality.Additional details: it was reported that "the patient reports tongue swelling and dyspnea.Dental filling inserted yesterday.Surgical consultation ordered.After the procedure, discharged in stable state with recommendations.Laboratory data included: ast (aspartate aminotransferase test) 36 u/l, ck (blood creatine phosphokinase) 126 u/l, crp (c-reactive protein) 1.0 mg/l, time 13.0 sec (normal range 11.00-17.00), prothrombin index 102% (normal range 70.00-130.00), inr (international normalized ratio) 0.97 (normal range 0.80-1.20), na (blood sodium)136 mmol/l (normal range 136-145), k (blood potassium) 4.9 mmol/l (normal range 3.5-5.1), gluc (blood glucagon) 112 mg/dl, 70-99 mg/dl normal fasting blood glucose level 100-125 mg/dl abnormal fasting blood glucose level, ogtt recommended = 126 mg/dl diabetes mellitus (after two tests in fasting condition), creatinine 1.5 mg/dl (normal range 0.8-1.4), wbc (white blood cells) 8.02 (normal range 4.00-10.00), rbc (red blood cells) 4.34 (normal range 3.90- 5.70), hgb (hemoglobin) 14.3 g/dl (normal range 12.0-17.0), hct (hematocrit) 42.4% (normal range 40.0- 54.0), mcv (mean cell volume) 97.7 fl (normal range 80.0- 96.0), mch (mean cell hemoglobin) 32.9 pg (normal range 27.0-34.0) mchc (mean cell hemoglobin concentration) 33.7 g/dl (normal range 33.0-36.0), rdw-cv () 14.3% (normal range 11.5-14.5), plt (platelet count) 150 (normal range 150-400), pdw (platelet distribution width) 11.7 fl (normal range 9.0- 17.0), mpv (mean platelet volume)10.2 fl (normal range 7.4-10.4), p-lcr (platelet-large cell ratio) 26.4% (normal range 19-47), pct (procalcitonin)0.15% (normal range 0.16-0.36), nrbc (nucleated red blood cells) 0.000.Diagnosis: swelling of the tongue and floor of the mouth on the left side.Odontogenic foci of infection.83-year-old male patient consulted by oral surgeon due to tongue swelling, which, according to the patient, developed today in the morning.Patient reports an episode of lower lip swelling on the left side, approximately 2 months ago after using denture fixative.No breathing disorders reported by the patient.Dysphagia reported.Pain reported to be at a level of 2 using nrs (0-10, where 0 is no pain).Patient with normal orientation to person, time and place.Cardiovascularly and respiratorily stable.Generic diseases: arterial hypertension, depression.Medications: lokren 20, zomiren 0.5, polfenon.Patient does not report allergies.Stimulants: denies.Extra-orally: facial symmetry maintained.Ocular motility maintained in 9 directions.Good vision.Round, symmetrical, correctly responding pupils.Patent nasal passage.Normal jaw grading: 4 cm.No pain at trigeminal pressure points.Intraorally: pink, smooth and glittering mucous membrane.Tooth no.37 visible with extensive filling and loss of hard tissues; painful in percussion test swelling of the tongue and floor of the mouth on the left side.No pus presence.Referred to opg x-ray that showed condition after root canal treatment and unfilled root canals of tooth 37.As part of oral cavity sanitation, tooth no.37 was extracted through alveolar chiseling with conduction anesthesia (2% lign+nor).During extraction process the mesial and distal root apex were broken.Curettage performed.Dressing applied.Patient was instructed.No indications for hospitalization at the department of oral and maxillofacial surgery follow up at (hospital oral and maxillofacial surgery outpatient clinic) on 21.09.2022 at 8-10:00 am or immediately in the case of deterioration of general or local status 2.Follow up opg x-ray in order to assess presence of remaining root canal apices of tooth 37.3.Cold packs on left cheek; avoid warming the treatment area 4.Standard diet 5.Avoid strenuous activity 6 increased oral hygiene 7.I suggest anti-allergic and antiedema therapy." follow up information was received on 11sep2023 from quality assurance (qa) department regarding product quality complaint with case number 05137771 for lot number jg4d.Investigation evaluation: this is the first complaint of this nature for this batch.No complaint sample was received to site.The retain sample was recalled to site and sent to the lab for testing.The testing of the retain sample has met the required quality standards.This case is deemed unsubstantiated.The investigation reports concluded that, complaint stands unsubstantiated.The pqc number was reported as pqc207088.Case correction was performed to the report received on 08aug2023.Seriousness criteria other is ticked and added haleon medically significant in the text box for the event anaphylactic shock.
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Search Alerts/Recalls
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