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

Device Problems Use of Device Problem (1670); Device Markings/Labelling Problem (2911)

Patient Problems Abdominal Pain (1685); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

1020379-2017-00028 is associated with argus case tw2017gsk030353, polident denture cleanser.

Event Description

Accidental ingestion [accidental device ingestion].Abdominal discomfort [abdominal discomfort].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a (b)(6) female patient who received double salt denture cleanser (polident denture cleanser) tablets for unknown indication.Concurrent medical conditions included influenza.On (b)(6) 2017, the patient started polident denture cleanser (dental) at an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced accidental device ingestion (serious criteria gsk medically significant), abdominal discomfort and product packaging confusion.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the accidental device ingestion and product packaging confusion were unknown and the outcome of the abdominal discomfort was recovering/resolving.The reporter considered the accidental device ingestion and abdominal discomfort to be related to polident denture cleanser.Additional details: initial and follow up processed together.The patient had flu.The patient's father mistook polident denture cleanser for cough effervescent tablets and gave the patient liquid made with polident denture cleanser to drink.The patient experienced abdominal discomfort after drinking the liquid.The patient consulted a physician who said there was "no major problem" with the patient.The patient recovered in the afternoon.

• Brand Name: POLIDENT DENTURE CLEANSER
• 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: 6395888
• MDR Text Key: 69646569
• Report Number: 1020379-2017-00028
• 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,foreign
• Type of Report: Initial
• Report Date: 03/02/2017

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: No Information
• Initial Date Manufacturer Received: 03/02/2017
• Initial Date FDA Received: 03/10/2017
• 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: 60 YR