MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Dyspnea (1816); Choking (2464); Foreign Body In Patient (2687)

Event Type  Death  

Manufacturer Narrative

Report # 3003721894-2018-00458 is associated with (b)(4), super poligrip cream.

Event Description

My husband passed away on (b)(6) 2018 [death].When the respiratory doctors found that there are super poligrip residue stuck in his throat, they had to vacuum it but they couldn't get the rest but they did their best.He was like choking [choking]; also, he couldn't breathe [difficulty breathing].Case description: this case was reported by a consumer and described the occurrence of death in a (b)(6) year-old male patient who received double salt dental adhesive cream (super poligrip free denture adhesive cream) cream (batch number unk, expiry date unknown) for denture wearer.The patient's past medical history included escherichia coli infection and (b)(6) infection.In 2000, the patient started super poligrip free denture adhesive cream.On an unknown date, an unknown time after starting super poligrip free denture adhesive cream, the patient experienced death (serious criteria death and gsk medically significant), choking (serious criteria gsk medically significant) and difficulty breathing.Super poligrip free denture adhesive cream was discontinued.On an unknown date, the outcome of the death was fatal and the outcome of the choking and difficulty breathing were unknown.The patient died on (b)(6) 2018.The reported cause of death was unknown cause of death.An autopsy was not performed.It was unknown if the reporter considered the death and difficulty breathing to be related to super poligrip free denture adhesive cream.The reporter considered the choking to be related to super poligrip free denture adhesive cream.Additional information: adverse event information was received via call on 26 december 2018.The patient's wife called and reported that, "my husband passed away on (b)(6) 2018.He had an ecoli and (b)(6) infection.He was in intensive care unit for a couple of weeks and he never improved.Also, he couldn't breathe.When the respiratory doctors found that there are super poligrip residue stuck in his throat, they had to vacuum it but they couldn't get the rest but they did their best.He was like choking.Start date of use over 8 years ago, stop date of use as soon as he got admitted at the hospital.".

Manufacturer Narrative

Mfr report is associated with argus case (b)(4), super poligrip cream.Please see the correction documented.

Event Description

My husband passed away on (b)(6) 2018 [death].He had an ecoli [escherichia coli infection].(b)(6).When the respiratory doctors found that there are super poligrip residue stuck in his throat, they had to vacuum it but they couldn't get the rest but they did their best.He was like choking [choking], [accidental device ingestion].Also, he couldn't breathe [difficulty breathing].Case description: this case was reported by a consumer and described the occurrence of death in a (b)(6) male patient who received double salt dental adhesive cream (super poligrip free denture adhesive cream) cream (batch number unk, expiry date unknown) for denture wearer.The patient's past medical history included escherichia coli infection and (b)(6) infection.In 2000, the patient started super poligrip free denture adhesive cream.On an unknown date, an unknown time after starting super poligrip free denture adhesive cream, the patient experienced death (serious criteria death and gsk medically significant), choking (serious criteria gsk medically significant) and difficulty breathing.Super poligrip free denture adhesive cream was discontinued.On an unknown date, the outcome of the death was fatal and the outcome of the choking and difficulty breathing were unknown.The patient died on (b)(6) 2018.The reported cause of death was unknown cause of death.An autopsy was not performed.It was unknown if the reporter considered the death and difficulty breathing to be related to super poligrip free denture adhesive cream.The reporter considered the choking to be related to super poligrip free denture adhesive cream.Additional information: adverse event information was received via call on 26 december 2018.The patient's wife called and reported that, "my husband passed away on (b)(6) 2018.He had an ecoli and (b)(6) infection.He was in intensive care unit for a couple of weeks and he never improved.Also, he couldn't breathe.When the respiratory doctors found that there are super poligrip residue stuck in his throat, they had to vacuum it but they couldn't get the rest but they did their best.He was like choking.Start date of use over 8 years ago, stop date of use as soon as he got admitted at the hospital." this report is being resubmitted to capture corrections for initial version dated on 26 december 2018.In this case historical conditions escherichia coli infection and (b)(6) infection and unknown cause of death were removed from previous report.Events 'escherichia coli infection, (b)(6) infection with hospitalization (seriousness criteria) and difficulty breathing were updated with outcome of event as fatal.Event of accidental device ingestion was added.Escherichia coli infection and (b)(6) infection and difficulty breathing were updated as cause of death.No more corrections were made.This report is being resubmitted to capture corrections for initial version dated on 26 december 2018.Outcome of events escherichia coli infection, (b)(6) infection and difficulty breathing was updated to unknown.Cause of death was unknown.It was unknown if the reporter considered the escherichia coli infection, (b)(6) infection and accidental device ingestion to be related to super poligrip free denture adhesive cream.No more corrections were made.

• Brand Name: SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709
• MDR Report Key: 8213600
• MDR Text Key: 131966643
• Report Number: 3003721894-2018-00458
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 12/26/2018
• Supplement Dates FDA Received: 01/24/2019
• 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): Death; Hospitalization; Other
• Patient Age: 78 YR