MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT; DENTURE CLEANSER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Dyspnea (1816); Edema (1820); Stenosis (2263); Low Oxygen Saturation (2477); Chemical Exposure (2570)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), polident.Report source literature description journal: author: title: 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.2018;12(1):291-294.Doi:10.1111/crj.12468.

Event Description

Bronchostenosis [bronchostenosis], dyspnoea [dyspnea], oedema mucosal [mucosal edema], eng:accidentally swallowed eight denture cleanser tablets [accidental ingestion of product].Case description: this case was detected in the medical literature by the glaxosmithkline literature monitoring service from 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.2018;12(1):291-294.This spontaneous case was reported in the medical literatu re by a healthcare professional from (b)(6) and concerns a (b)(6) male patient who experienced serious adverse reactions of bronchial stenosis, mucosal edema in upper airway and severe dyspnea associated with accidental ingestion of denture cleanser tablets (polident).The patient with dementia was referred because of dyspnea.He accidentally swallowed eight denture cleanser tablets (polident).Although he immediately spat them out, he felt difficulty in breathing.On arrival at the emergency department, oxygen desaturation (more 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.Follow up information has been requested.

Manufacturer Narrative

Argus case (b)(4).(b)(4)is a duplicate for case (b)(4).

Event Description

This case was detected in the medical literature by the glaxosmithkline literature monitoring service from 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.2018;12(1):291-294.This spontaneous case was reported in the medical literature by a healthcare professional from japan and concerns a 78-year-old male patient who experienced serious adverse reactions of bronchial stenosis, mucosal edema in upper airway and severe dyspnea associated with accidental ingestion of denture cleanser tablets (polident).The patient with dementia was referred because of dyspnea.He accidentally swallowed eight denture cleanser tablets (polident).Although he immediately spat them out, he felt difficulty in breathing.On arrival at the emergency department, oxygen desaturation (more 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.Follow up information has been requested.Follow-up received on 20mar0219, gsk case number (b)(4) is a duplicate of (b)(4).All future correspondence will be submitted to (b)(4).

• Brand Name: POLIDENT
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 7307545
• MDR Text Key: 101344444
• Report Number: 1020379-2018-00015
• 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
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR