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

Device Problem Insufficient Information (3190)

Patient Problem Chemical Exposure (2570)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Caller's mother ingested a polident tablet [accidental device ingestion].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a elderly female patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for dental cleaning.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 (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to polident denture cleanser tablets.Additional details, the adverse event information was received on 15 february 2018.The caller's mother ingested a polident tablet.

Manufacturer Narrative

1020379-2018-00012 is associated with (b)(4), polident denture cleanser tablets.

Event Description

Caller's mother ingested a polident tablet [accidental device ingestion] his mother is currently in the hospital [hospitalization] case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a elderly female patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for dental cleaning.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 (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to polident denture cleanser tablets.Additional details, the adverse event information was received on 15 february 2018.The caller's mother ingested a polident tablet.Follow up information was received on 23 february 2018.The reporter stated his mother was currently in the hospital.The reporter was unsure if this hospitalization if related to the initial event reported.The hospitalization event was added to the case.The event outcome for hospitalization event was unknown.It was unknown if the reporter considered the hospitalization to be related to polident denture cleanser tablets.

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC; memphis TN
• MDR Report Key: 7285025
• MDR Text Key: 100527660
• Report Number: 1020379-2018-00012
• 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,Followup
• Report Date: 02/15/2018

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: Lay User/Patient
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 02/23/2018
• Supplement Dates FDA Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other