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

Device Problem Human-Device Interface Problem (2949)

Patient Problem Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

1020379-2016-00055 is associated with (b)(4), polident.

Event Description

Swallowed one of the tablets [accidental device ingestion]; he put water into his system, as well as sticking his finger down his throat in order to make himself vomit [self-induced vomiting].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a male patient who received double salt denture cleanser (polident) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident 1 dosage form(s) at an unknown frequency.On an unknown date, an unknown time after starting polident, the patient experienced accidental device ingestion (serious criteria gsk medically significant), self-induced vomiting and accidental ingestion of drug.The action taken with polident was unknown.On an unknown date, the outcome of the accidental device ingestion, self-induced vomiting and accidental ingestion of drug were unknown.It was unknown if the reporter considered the accidental device ingestion and self-induced vomiting to be related to polident.Additional details, adverse event information was reported by consumer on 25 october 2016.Consumer reported accidental ingestion of product by adult as he stated that he swallowed one of the tablets (accidental device ingestion and accidental ingestion of drug ), but not all the way.Consumer reported vomiting as he stated that he put water into his system, as well as sticking his finger down his throat in order to made himself vomit.

• 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: 6066733
• MDR Text Key: 58743103
• Report Number: 1020379-2016-00055
• 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: 10/25/2016

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: 10/25/2016
• Initial Date FDA Received: 10/31/2016
• 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