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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Mfr #: 1020379-2018-00075 is associated with (b)(4), 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 female patient who received denture cleanser (polident denture cleanser) unknown 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 not reported.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 details: the consumer reported that she swallowed the solution by accident and read in the box to call poison control in case you swallow it.She did not have the phone number for poison control and did not have a doctor to see.Age not provided.

• Brand Name: POLIDENT DENTURE CLEANSER
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 8183080
• MDR Text Key: 130982704
• Report Number: 1020379-2018-00075
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 12/12/2018
• 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