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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Stomach ache [stomach pain].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion by a child in a (b)(6) male patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.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 by a child (serious criteria gsk medically significant) and stomach ache.The action taken with polident denture cleanser tablets was unknown (dechallenge was unknown).On an unknown date, the outcome of the accidental device ingestion by a child and stomach ache were unknown.It was unknown if the reporter considered the stomach ache to be related to polident denture cleanser tablets.Additional details, consumer reported that a male child accidentally ingested the product (accidental device ingestion by child).He stated the boy swallowed an unspecified amount of the product and experienced a stomach ache.Once provided with the poison control contact number, the consumer stated he needed to disconnect the call to contact poison control.

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• 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: 5790497
• MDR Text Key: 49422779
• Report Number: 1020379-2016-00022
• 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: 06/09/2016

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: 06/09/2016
• Initial Date FDA Received: 07/13/2016
• 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: 13 YR