MAUDE Adverse Event Report: BLOCK DRUG CO., INC. JAPANESE POLIDENT FOR PARTIALS(WITH SODIUM PERCARBONATE)-MFC51038; DENTURE CLEANSER

Device Problem Insufficient Information (3190)

Patient Problems Abnormal Blood Gases (1034); Vomiting (2144); Dizziness (2194)

Event Date 05/06/2016

Event Type  Injury  

Manufacturer Narrative

Report # 1020379-2016-00010 is associated with argus case (b)(4); japanese polident for partials(with sodium percarbonate)-mfc51038.Japanese polident for partials (with sodium percarbonate)-mfc51038 is marketed as polident tablets in the us.

Event Description

Blood gases abnormal [blood gases abnormal].Vomiting [vomiting].Dizziness [dizziness].Case description: this case was reported by a physician via out of hour services and described the occurrence of blood gases abnormal in a (b)(6) year-old female patient who received double salt denture cleanser (japanese polident for partials(with sodium percarbonate)-mfc51038) tablet for an unknown indication.Concurrent medical conditions included dementia.On an unknown date, the patient started japanese polident for partials(with sodium percarbonate)-mfc51038.On (b)(6) 2016, less than an hour after starting japanese polident for partials(with sodium percarbonate)-mfc51038, the patient experienced blood gases abnormal (serious criteria hospitalization) and accidental ingestion of product.In (b)(6) 2016, the patient experienced vomiting (serious criteria hospitalization) and dizziness (serious criteria hospitalization).In (b)(6) 2016, the outcome of the blood gases abnormal, vomiting and dizziness were recovered/resolved.On an unknown date, the outcome of the accidental ingestion of product was unknown.It was not reported if the reporter considered the blood gases abnormal, vomiting and dizziness to be related to japanese polident for partials(with sodium percarbonate)-mfc51038.The patient ingested 2 tablets of japanese polident for partials (with sodium percarbonate)-mfc51038 (accidental ingestion of product).The follow-up investigation was done on 18 may 2016.Circumstances: no additional information was received.Symptoms: vomiting, dizziness, and abnormal blood gases (these events were improved.) outcome: resolved (2-day hospitalization).

• Brand Name: JAPANESE POLIDENT FOR PARTIALS(WITH SODIUM PERCARBONATE)-MFC51038
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5679377
• MDR Text Key: 45922259
• Report Number: 1020379-2016-00010
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2016

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 05/25/2016
• 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: 90 YR
• Patient Weight: 40