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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The report # 1020379-2017-00081 is associated with (b)(4), polident.

Event Description

Mother ate a tablet of polident by accident [accidental device ingestion].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a female patient who received double salt denture cleanser (polident) tablet (batch number unk, expiry date unknown) for drug use for unknown indication.On an unknown date, the patient started polident.On an unknown date, an unknown time after starting polident, 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.Additional information: adverse event information was received on (b)(4) 2017.The consumer was calling for mother asking do the poligrip strips dissolve in her mouth and what would happen if her mother swallowed a polident tablet.She stated a few months ago her mother ate a tablet of polident by accident and they brought her to the doctor.The action taken with suspect was "not applicable" with dechallenge as "not applicable".

• Brand Name: POLIDENT
• 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: 7108246
• MDR Text Key: 94533730
• Report Number: 1020379-2017-00081
• 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: 12/04/2017

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: 12/04/2017
• Initial Date FDA Received: 12/12/2017
• 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