• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER (UNKNOWN) Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Death (1802); Asphyxia (1851); Foreign Body Sensation in Eye (1869); Laceration(s) (1946); Pneumonia (2011); Respiratory Distress (2045); Swelling (2091); Injury (2348); Loss of consciousness (2418)
Event Date 01/04/2015
Event Type  Death  
Event Description
Pneumonia, respiratory arrest, loss of consciousness, cough, productive cough, sensation of foreign body, laceration, swelling.Case description: this case was reported by a non-health professional via call center representative and described the occurrence of pneumonia in a (b)(6) male patient who received double salt denture cleanser (polident denture cleanser (unknown) tablet for an unknown indication.Concurrent medical conditions included denture wearer.On an unknown date, the patient started polident denture cleanser (unknown).On (b)(6) 2015, unknown after starting polident denture cleanser (unknown), the patient experienced cough, drooling, lump feeling in throat and pharyngeal injury (serious criteria gsk medically significant).On (b)(6) 2015, the patient experienced respiratory arrest (serious criteria gsk medically significant) and loss of consciousness (serious criteria gsk medically significant).On an unknown date, the patient experienced pneumonia (serious criteria death and gsk medically significant), throat swelling and accidental ingestion of product.The patient was treated with fexofenadine hydrochloride (allegra) and cefditoren pivoxil (meiact).On (b)(6) 2015, the outcome of the pneumonia was fatal.On an unknown date, the outcome of the respiratory arrest and loss of consciousness were recovered/resolved and the outcome of the cough, drooling, lump feeling in throat, pharyngeal injury, throat swelling and accidental ingestion of product were unknown.The patient died on (b)(6) 2015.The reported cause of death was pneumonia.It was not reported if the reporter considered the pneumonia, respiratory arrest, loss of consciousness, cough, drooling, lump feeling in throat, pharyngeal injury and throat swelling 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.On (b)(6) 2015, the patient accidentally ingested a tablet of polident denture cleanser (unknown).The event occurred after dinner.When the event was discovered, the patient was trying to expectorate something while cleansing dentures.Cough and expectoration were subsequently noted by a facility nurse.The patient complained of lump feeling in throat but had no nausea.The case was reported to the (b)(6), which searched a hospital for the patient.The patient visited hospital c in neighbourhood, where pharyngeal injury was diagnosed presumably based on the result of endoscopy.At that time, instructions were given to perform gastroscopy on the following day.As a transesophageal gastroscopy could not be used in state of erosion, instructions were given not to have breakfast but to drink water or lukewarm water.Allegra (fexofenadine hydrochloride) and meiact (cefditoren pivoxil) were prescribed.On (b)(6) 2015, the patient had no breakfast and took prescribed drugs, and visited hospital d.In order not to aggravate the existing pharyngeal injury, gastroscopy was not performed.The patient visited the department of otolaryngology at hospital e.At the department of otolaryngology at hospital e, a physician pointed out swelling at the entrance of the esophagus (throat swelling), and stated that further swelling could result in asphyxia.The patient was referred to hospital a and admitted there.On (b)(6) 2015, respiratory arrest developed at the time of breakfast, but the patient was resuscitated.The patient received hypothermia therapy at the intensive care unit (icu) for 3 days, and regained consciousness.On (b)(6) 2015, the patient was transferred from the icu to a general ward.On (b)(6) 2015, the patient was transferred to hospital b.The reason for the hospital transfer was unknown as the reporter had not been informed of.On (b)(6) 2015, the patient died.The cause of death recorded in the death certificate was pneumonia.A medical representative requested the cooperation for confirmation as to whether consent to receive the opinion of the physician of the hospital the patient had first visited could be obtained from the bereaved families, but were refused.In addition, the medical representative asked the staff who had accompanied the patient to the hospital whether any opinion of the physician had been obtained, but could not get a response from the staff.Therefore, no further information was available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POLIDENT DENTURE CLEANSER (UNKNOWN)
Type of Device
DENTURE CLEANSER
Manufacturer (Section D)
BLOCK DRUG CO., INC.
memphis TN
Manufacturer (Section G)
GSK
Manufacturer Contact
p.o box 13398
research triangle park, NC 27709
8888255249
MDR Report Key5017355
MDR Text Key23668750
Report Number1020379-2015-00012
Device Sequence Number1
Product Code EFT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Report Date 07/29/2015
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 Not provided
Initial Date FDA Received08/18/2015
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 Number1
Patient Outcome(s) Death; Other;
Patient Age95 YR
-
-