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

Lot Number 5T12163

Device Problem Insufficient Information (3190)

Patient Problem Abscess (1690)

Event Date 02/01/2014

Event Type  Other  

Event Description

This case was reported by a consumer and described the occurrence of liver abscess in a male pt of unspecified age who received double salt denture cleanser (polident denture cleanser) for dental care.A physician or other health care professional has not verified this report.Concurrent medical conditions included surgery.In (b)(6) 2013 the patient started double salt denture cleanser (dental) daily.Approx 3 months later, in (b)(6) 2014, the pt experienced liver abscess.The pt received treatment with surgery and antibiotics.The pt wanted to know if any ingredient in double salt denture cleanser could make liver function worse, as although he cleaned his dentures with water each time after using the cleanser, he could take in a very small amount of double salt denture cleanser (accidental ingestion of product).This case was assessed as medically serious by gsk.Treatment with double salt denture cleanser was continued.At the time of reporting, the outcome of the events was unk.

Manufacturer Narrative

The mfr report number for this case is 1020379-2014-00003.Polident denture cleanser is manufactured in (b)(4).The lot number for this product is 5t12163.(b)(4).

• Brand Name: POLIDENT DENTURE CLEANSER
• Type of Device: DOUBLE SALT DENTURE CLEANSER
• Manufacturer (Section D): GLAXOSMITHKLINE; rtp NC 27709
• Manufacturer (Section G): BLOCK DRUG CO., INC.; 2149 harbor ave.; memphis TN 38113
• Manufacturer Contact: po box 13398; rtp, NC 27709 ; 8888255249
• MDR Report Key: 3772234
• MDR Text Key: 4357080
• Report Number: 1020379-2014-00003
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: KN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/01/2014

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: Lay User/Patient
• Device Expiration Date: 04/30/2015
• Device Lot Number: 5T12163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2014
• Initial Date FDA Received: 04/02/2014
• 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
• Treatment: UNSPECIFIED
• Patient Outcome(s): Other
• Patient Age: 79 YR