MAUDE Adverse Event Report: BLOCK DRUG CO., INC. JAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED); DENTURE CLEANSER

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The 1020379-2018-00026 is associated with argus case (b)(4), (b)(6) polident for partials (polident for partials with taed).(b)(6) polident for partials (polident for partials with taed) is marketed as polident tablets in the us.

Event Description

Hospitalisation.Case description: this case was reported by a consumer via call center representative and described the occurrence of hospitalisation in a male patient who received denture cleanser (japanese polident for partials (polident for partials with taed)) tablet for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started japanese polident for partials (polident for partials with taed).On an unknown date, an unknown time after starting (b)(6) polident for partials (polident for partials with taed), the patient experienced hospitalisation (serious criteria hospitalization and gsk medically significant).The action taken with (b)(6) polident for partials (polident for partials with taed) was unknown.On an unknown date, the outcome of the hospitalisation was unknown.It was unknown if the reporter considered the hospitalisation to be related to japanese polident for partials (polident for partials with taed).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Clinical course: the patient was using japanese polident for partials (polident for partials with taed) by dissolving in the lukewarm water at about 40 degrees celsius.He was scheduled to be admitted to the hospital for about three weeks.The reason for hospitalization was unknown.No further information is expected.

• Brand Name: JAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer Contact: po box 13398; research triangle park, NC 27709
• MDR Report Key: 7621855
• MDR Text Key: 111764421
• Report Number: 1020379-2018-00026
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 06/14/2018

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: No Information
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 06/20/2018
• 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; Other