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

Device Problem Insufficient Information (3190)

Patient Problems Chemical Exposure (2570); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

1020379-2017-00053 is associated with argus case tw2017gsk103491, polident denture cleanser.

Event Description

Accidental ingestion [accidental device ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a male patient who received double salt denture cleanser (polident denture cleanser) tablet for product used for unknown indication.On an unknown date, the patient started polident denture cleanser.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the accidental device ingestion was unknown.The reporter considered the accidental device ingestion to be related to polident denture cleanser.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: the consumer swallowed polident denture cleanser tablet accidentally.The consumer did not agree to be contacted by gsk for further follow-up.

• 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: 6693756
• MDR Text Key: 79292814
• Report Number: 1020379-2017-00053
• 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: 07/04/2017

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: 07/04/2017
• Initial Date FDA Received: 07/07/2017
• 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