MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER TABLETS

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus case (b)(4), polident denture cleanser tablets.

Event Description

Her (b)(6) child had taken a piece of the polident tablets.Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion by a child in a (b)(6) patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident denture cleanser tablets.On an unknown date, an unknown time after starting polident denture cleanser tablets, the patient experienced accidental device ingestion by a child (serious criteria gsk medically significant) and accidental drug intake by child.On an unknown date, the outcome of the accidental device ingestion by a child and accidental drug intake by child were unknown.It was unknown if the reporter considered the accidental device ingestion by a child to be related to polident denture cleanser tablets.Additional details, adverse event information was reported on 23 february 2017.The consumer reported that her (b)(6) child had taken a piece of the polident tablets (through a (b)(6) speaking interpreter).

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• 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: 6361114
• MDR Text Key: 68415355
• Report Number: 1020379-2017-00025
• 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
• Type of Report: Initial
• Report Date: 02/23/2017

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
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 02/27/2017
• 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: 1 YR