MAUDE Adverse Event Report: GSK MEMPHIS FACILITY BLOCK DRUG JAPANESE POLIDENT FOR PARTIALS (WITH SODIUM PERCARBONATE)-MFC51038; DENTURE CLEANSER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Loss of consciousness (2418)

Event Date 02/12/2015

Event Type  No Answer Provided  

Event Description

Altered state of consciousness [consciousness disturbed] case description: this case was reported by a non-health professional via call center rep and described the occurrence of consciousness disturbed in a (b)(6) female pt who received double salt denture cleanser ((b)(4) polident for partials (with sodium percarbonate)-mfc51038) tablet for an unk indication.On an unk date, the pt started (b)(4) polident for partials (with sodium percarbonate)-mfc51038.On (b)(6) 2015, o mins after starting (b)(4) polident for partials (with sodium percarbonate)-mfc51038, the pt experienced consciousness disturbed (serious criteria gsk medically significant and accidental ingestion of product.On (b)(6) 2015, the outcome of the consciousness disturbed was recovering/resolving and the outcome of the accidental ingestion of product was unk.It was not reported if the reporter considered the consciousness disturbed to be related to (b)(4) polident for partials (with sodium percarbonate)-mfc51038.On (b)(6) 2015: around 15:00, the pt ingested 2 to 3 tablets of (b)(4) polident for partials (polident for partials with taed) and fell into a twilight state (accidental exposure to product, altered state of consciousness).Then the pt gradually regained consciousness in about 30 minutes, and became able to have a conversation.

• Brand Name: JAPANESE POLIDENT FOR PARTIALS (WITH SODIUM PERCARBONATE)-MFC51038
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): GSK MEMPHIS FACILITY BLOCK DRUG; memphis TN
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 4544394
• MDR Text Key: 17209435
• Report Number: 1020379-2015-00006
• 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
• Type of Report: Initial
• Report Date: 02/12/2015

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: Other
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 02/23/2015
• 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): Other
• Patient Age: 93 YR