MAUDE Adverse Event Report: GLAXOSMITHKLINE POLIDENT DENTURE CLEANSER TABLETS; DOUBLE SALT DENTURE CLEANSER

Lot Number MA1513

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Vomiting (2144); Dizziness (2194); No Code Available (3191)

Event Date 02/02/2014

Event Type  Other  

Manufacturer Narrative

Follow up received on 10 february 2014 from the consumer: the batch details for polident denture cleanser tablets was provided as ma1513; expiry date 14 jan 2016.The consumer reported that the event of aggravated vomiting improved on (b)(6) 2014.At the time of reporting, the cardiac problems was unresolved.The pt was advised by a doctor to take some rest and nourishing food.The mfr's report number for this case is 1020379-2014-00002.Polident tablets are manufactured in (b)(4).The lot number for this report is available ma1513, expiration 14 january 2016.It is unk if the product will be returned for qa testing.

Event Description

This case was reported by a consumer (pt's son) and described the occurrence of vomiting aggravated in a (b)(6) female pt who received double salt denture cleanser (polident denture cleanser tablets) tablet over a period of 2 days for dentures.A physician or other healthcare professional has not verified this report.Concurrent medical conditions included dizziness and vomiting.On (b)(6) 2014, the pt started double salt denture cleanser (dental) according to the instructions.She soaked the denture through the night.On the morning of (b)(6) 2014, she wore the denture after washing it with a clear water.Approximately 1 day later, on the morning of (b)(6) 2014, she wore the denture after washing it with clear water experienced vomiting aggravated.The vomiting was worse than before.The pt was hospitalized.The result given by the hospital was that the severe vomiting caused cardiac problems and the pt required to be hospitalized.Treatment with double salt denture cleanser was discontinued.At the time of reporting, the events were unresolved.

Event Description

This case was reported by a consumer (pt's son) and described the occurrence of vomiting aggravated in a (b)(6) female pt who received double salt denture cleanser (polident denture cleanser tablets) tablet over a period of 2 days for dentures.A physician or other healthcare professional has not verified this report.Concurrent medical conditions included dizziness and vomiting.On (b)(6) 2014, the pt started double salt denture cleanser (dental) according to the instructions.She soaked the denture through the night.On the morning of (b)(6) 2014, she wore the denture after washing it with a clear water.Approximately 1 day later, on the morning of (b)(6) 2014, she wore the denture after washing it with clear water experienced vomiting aggravated.The vomiting was worse than before.The pt was hospitalized.The result given by the hospital was that the severe vomiting caused cardiac problems and the pt required to be hospitalized.Treatment with double salt denture cleanser was discontinued.At the time of reporting, the events were unresolved.

Manufacturer Narrative

Follow up received on 10 february 2014 from the consumer: the batch details for polident denture cleanser tablets was provided as ma1513; expiry date 14 jan 2016.The consumer reported that the event of aggravated vomiting improved on (b)(6) 2014.At the time of reporting, the cardiac problems was unresolved.The pt was advised by a doctor to take some rest and nourishing food.The mfr's report number for this case is 1020379-2014-00002.Polident tablets are manufactured in (b)(4).The lot number for this report is available ma1513, expiration 14 january 2016.It is unk if the product will be returned for qa testing.

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• Type of Device: DOUBLE SALT DENTURE CLEANSER
• Manufacturer (Section D): GLAXOSMITHKLINE; research triangle park NC 27709
• Manufacturer (Section G): BLOCK DRUG CO., INC. MEMPHES FACILITY; 2149 harbor ave.; memphis TN 38113
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 3662546
• MDR Text Key: 21272178
• Report Number: 1020379-2014-00002
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Type of Report: Initial
• Report Date: 02/17/2014

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: Health Professional
• Device Expiration Date: 01/14/2016
• Device Lot Number: MA1513
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2014
• Initial Date FDA Received: 02/18/2014
• 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): Hospitalization
• Patient Age: 70 YR