MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER (UNKNOWN)

Device Problem Insufficient Information (3190)

Patient Problems Aspiration/Inhalation (1725); Dyspnea (1816); Edema (1820); Erythema (1840); Respiratory Distress (2045); Swelling (2091); Stenosis (2263); Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4) polident denture cleanser (unknown).

Event Description

Constricted glottis [glottic edema].Accidental device ingestion [accidental device ingestion].Mucosal edema [mucosal edema].Case description: this case was reported in a literature article and described the occurrence of mucosal edema in a (b)(6) male patient who received double salt denture cleanser (polident) unknown for drug use for unknown indication.(ochi n, yamane h, honda y, takigawa n.Accidental aspiration of denture cleanser tablets caused severe mucosal edema in upper airway.The clinical respiratory journal 2016; :.) on an unknown date, the patient started polident.On an unknown date, an unknown time after starting polident, the patient experienced mucosal edema, accidental device ingestion (serious criteria gsk medically significant) and oedema glottis (serious criteria gsk medically significant).On an unknown date, the outcome of the mucosal edema, accidental device ingestion and oedema glottis were unknown.The reporter considered the mucosal edema, accidental device ingestion and oedema glottis to be related to polident.Additional details: a (b)(6) man with dementia was referred because of dyspnea.He accidentally swallowed eight denture cleanser tablets (polidentvr ).Although he immediately spat them out, he felt difficulty in breathing.On arrival at our emergency department, oxygen desaturation (less than 90%) measured by pulse oximetry was observed.Allergic or anaphylactic reactions were not observed.Because inspiratory stridor around anterior neck was auscultated, upper airway stenosis was speculated.Computed tomography (ct) image showed thickness of soft tissue density from middle larynx to posterior membranous portion of the trachea especially around the epiglottis and bilateral main bronchial stenosis.The bronchoscopic observation revealed constricted glottis with edema and redness.The instillation of 1% xylocaine with epinephrine (1:100 000 dilution) to epiglottis and larynx reduced edema and enabled the bronchoscope to pass the glottis.The red and edematous mucosa of the trachea and major bronchus was also observed.Soon after the bronchoscopic procedure, his stridor and dyspnea were relieved and ct image confirmed improvement of bilateral main bronchial stenosis.Because posterior membranous portion of the trachea was still thickened, he received hydrocortisone and methylprednisolone intravenously for several days.At 4 days, the edema of the larynx and epiglottis fully recovered.The authors stated "we herein described that an old man with dementia, who accidentally ingested denture cleanser tablets, had severe dyspnea due to the mucosal edema of the larynx and the posterior membranous portion of the trachea".

Manufacturer Narrative

This report is associated with argus case (b)(4) polident denture cleanser (unknown).Report source literature description: journal: the clinical respiratory journal, author: ochi n, yamane h, honda y, takigawa n, title: accidental aspiration of denture cleanser tablets caused severe mucosal edema in upper airway, year: 2016.

Event Description

Laryngeal oedema.Mucosal edema.Bronchostenosis.Pharyngeal stenosis.Laryngeal stenosis.Dyspnoea.Stridor.Regurgitation.Laryngotracheal oedema.Case description: this case was reported in a literature article and described the occurrence of laryngotracheal oedema in a (b)(6) male patient who received double salt denture cleanser (polident denture cleanser (unknown)) tablet for denture wearer.(ochi n, yamane h, honda y, takigawa n.Accidental aspiration of denture cleanser tablets caused severe mucosal edema in upper airway.The clinical respiratory journal 2016; :.) concurrent medical conditions included dementia, denture wearer and hospitalisation.Concomitant products included ethyl icosapentate (epadel), amlodipine, sennosides (sennoside), paroxetine, olanzapine, zopiclone, mirtazapine, flunitrazepam and saikokaryukotsuboreito.On an unknown date, the patient started polident denture cleanser (unknown).On an unknown date, unknown after starting polident denture cleanser (unknown), the patient experienced laryngotracheal oedema (serious criteria gsk medically significant and life threatening), mucosal edema (serious criteria life threatening), bronchostenosis (serious criteria gsk medically significant), pharyngeal stenosis (serious criteria gsk medically significant), laryngeal stenosis (serious criteria gsk medically significant), dyspnoea, stridor inspiratory, regurgitation and accidental ingestion of product.The patient was treated with hydrocortisone sodium succinate (saxizon), lidocaine (xylocaine) and methylprednisolone.On an unknown date, the outcome of the laryngotracheal oedema, mucosal edema, bronchostenosis, pharyngeal stenosis, laryngeal stenosis, dyspnoea, stridor inspiratory and regurgitation were recovered/resolved and the outcome of the accidental ingestion of product was unknown.The reporter considered the laryngotracheal oedema and mucosal edema to be probably related to polident denture cleanser (unknown).It was unknown if the reporter considered the bronchostenosis, pharyngeal stenosis, laryngeal stenosis, dyspnoea, stridor inspiratory and regurgitation to be related to polident denture cleanser (unknown).Additional details: a (b)(6) man with dementia was referred because of dyspnea.He accidentally swallowed eight denture cleanser tablets (polident vr ).Although he immediately spat them out, he felt difficulty in breathing.On arrival at our emergency department, oxygen desaturation (less than 90%) measured by pulse oximetry was observed.Allergic or anaphylactic reactions were not observed.Because inspiratory stridor around anterior neck was auscultated, upper airway stenosis was speculated.Computed tomography (ct) image showed thickness of soft tissue density from middle larynx to posterior membranous portion of the trachea especially around the epiglottis and bilateral main bronchial stenosis.The bronchoscopic observation revealed constricted glottis with edema and redness.The instillation of 1% xylocaine with epinephrine (1:100 000 dilution) to epiglottis and larynx reduced edema and enabled the bronchoscope to pass the glottis.The red and edematous mucosa of the trachea and major bronchus was also observed.Soon after the bronchoscopic procedure, his stridor and dyspnea were relieved and ct image confirmed improvement of bilateral main bronchial stenosis.Because posterior membranous portion of the trachea was still thickened, he received hydrocortisone and methylprednisolone intravenously for several days.At 4 days, the edema of the larynx and epiglottis fully recovered.The authors stated "we herein described that an old man with dementia, who accidentally ingested denture cleanser tablets, had severe dyspnea due to the mucosal edema of the larynx and the posterior membranous portion of the trachea".Follow-up information received from the reporting physician on 27 december 2016.[clinical course]: the patient accidentally ingested about 8 tablets of polident denture cleanser (unknown) during hospitalization at a near-by hospital.He vomited and his respiratory status worsened and he was referred to the reporting hospital.On arrival at the emergency department of the reporting hospital, significant stenotic sound was noted.From the images on computed tomography (ct), edema from pharynx to trachea was suspected.In bronchoscopy, laryngopharyngeal stenosis, which was grossly significant, due to mucosal edema was noted.During the above examinations, drip infusion of saxizon was given to the patient.To subside tracheal edema, xylocaine combined with 1% of adrenaline was sprayed.Thereafter, respiratory sound and oxygenation improved.It took four to five days until the patient achieved complete recovery.[reporter's comment]: since the patient threw up after the accidental ingestion of polident, the reporting physician considered that certain interaction between gastric acid and residual polident around might have pharynx occurred.Erosion subsided as the result; however, there was no established data that supports the effectiveness of the treatment this time.In accordance with the general treatment for anaphylaxis, steroid and xylocaine combined with 1% of adrenaline were given.

Event Description

This case was reported in a literature article and described the occurrence of laryngotracheal oedema in a 78-year-old male patient who received double salt denture cleanser (polident denture cleanser (unknown)) tablet for denture wearer.(ochi n, yamane h, honda y, takigawa n.Accidental aspiration of denture cleanser tablets caused severe mucosal edema in upper airway.The clinical respiratory journal 2016; :.) concurrent medical conditions included dementia, denture wearer and hospitalisation.Concomitant products included ethyl icosapentate (epadel), amlodipine, sennosides (sennoside), paroxetine, olanzapine, zopiclone, mirtazapine, flunitrazepam and saikokaryukotsuboreito.On an unknown date, the patient started polident denture cleanser (unknown).On an unknown date, unknown after starting polident denture cleanser (unknown), the patient experienced laryngotracheal oedema (serious criteria gsk medically significant and life threatening), mucosal edema (serious criteria life threatening), bronchostenosis (serious criteria gsk medically significant), pharyngeal stenosis (serious criteria gsk medically significant), laryngeal stenosis (serious criteria gsk medically significant), dyspnoea, stridor inspiratory, regurgitation and accidental ingestion of product.The patient was treated with hydrocortisone sodium succinate (saxizon), lidocaine (xylocaine) and methylprednisolone.On an unknown date, the outcome of the laryngotracheal oedema, mucosal edema, bronchostenosis, pharyngeal stenosis, laryngeal stenosis, dyspnoea, stridor inspiratory and regurgitation were recovered/resolved and the outcome of the accidental ingestion of product was unknown.The reporter considered the laryngotracheal oedema and mucosal edema to be probably related to polident denture cleanser (unknown).It was unknown if the reporter considered the bronchostenosis, pharyngeal stenosis, laryngeal stenosis, dyspnoea, stridor inspiratory and regurgitation to be related to polident denture cleanser (unknown).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details a 78-year-old man with dementia was referred because of dyspnea.He accidentally swallowed eight denture cleanser tablets (polidentvr ).Although he immediately spat them out, he felt difficulty in breathing.On arrival at our emergency department, oxygen desaturation (less than 90%) measured by pulse oximetry was observed.Allergic or anaphylactic reactions were not observed.Because inspiratory stridor around anterior neck was auscultated, upper airway stenosis was speculated.Computed tomography (ct) image showed thickness of soft tissue density from middle larynx to posterior membranous portion of the trachea especially around the epiglottis and bilateral main bronchial stenosis.The bronchoscopic observation revealed constricted glottis with edema and redness.The instillation of 1% xylocaine with epinephrine (1:100 000 dilution) to epiglottis and larynx reduced edema and enabled the bronchoscope to pass the glottis.The red and edematous mucosa of the trachea and major bronchus was also observed.Soon after the bronchoscopic procedure, his stridor and dyspnea were relieved and ct image confirmed improvement of bilateral main bronchial stenosis.Because posterior membranous portion of the trachea was still thickened, he received hydrocortisone andmethylprednisolone intravenously for several days.At 4 days, the edema of the larynx and epiglottis fully recovered.The authors stated "we herein described that an old man with dementia, who accidentally ingested denture cleanser tablets, had severe dyspnea due to the mucosal edema of the larynx and the posterior membranous portion of the trachea".Follow-up information received from the reporting physician on 27 december 2016 [clinical course] the patient accidentally ingested about 8 tablets of polident denture cleanser (unknown) during hospitalization at a near-by hospital.He vomited and his respiratory status worsened and he was referred to the reporting hospital.On arrival at the emergency department of the reporting hospital, significant stenotic sound was noted.From the images on computed tomography (ct), edema from pharynx to trachea was suspected.In bronchoscopy, laryngopharyngeal stenosis, which was grossly significant, due to mucosal edema was noted.During the above examinations, drip infusion of saxizon was given to the patient.To subside tracheal edema, xylocaine combined with 1% of adrenaline was sprayed.Thereafter, respiratory sound and oxygenation improved.It took four to five days until the patient achieved complete recovery.[reporter's comment] since the patient threwup after the accidental ingestion of polident, the reporting physician considered that certain interaction between gastric acid and residual polident around might have pharynx occurred.Erosion subsided as the result; however, there was no established data that supports the effectiveness of the treatment this time.In accordance with the general treatment for anaphylaxis, steroid and xylocaine combined with 1% of adrenaline were given.Follow-up received on 20mar0219, gsk case number jp2018031715 is a duplicate of jp2016gsk043453.All future correspondence will be submitted to jp2016gsk043453.

Manufacturer Narrative

Argus case (b)(4).

• Brand Name: POLIDENT DENTURE CLEANSER (UNKNOWN)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• MDR Report Key: 5548239
• MDR Text Key: 41909468
• Report Number: 1020379-2016-00004
• 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: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2016

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: No Information
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided; 03/20/2019
• Supplement Dates FDA Received: 01/17/2017; 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 78 YR