MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 3 MINUTE; DENTURE CLEANSER

Lot Number MP1312

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Nausea (1970); Chemical Exposure (2570)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

Mfr 1020379-2017-00058 is associated with argus case (b)(4), polident 3 minute.

Event Description

I accidently swallowed the polident 3-minute 120ct solution [accidental device ingestion] did feel a little queasy [feeling queasy].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) female patient who received double salt denture cleanser (polident 3 minute) tablet (batch number mp1312, expiry date unknown) for dental cleaning.On (b)(6) 2017, the patient started polident 3 minute.On (b)(6) 2017, less than a day after starting polident 3 minute, the patient experienced accidental device ingestion (serious criteria gsk medically significant), feeling queasy and accidental ingestion of drug.On an unknown date, the outcome of the accidental device ingestion and accidental ingestion of drug were unknown and the outcome of the feeling queasy was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion and feeling queasy to be related to polident 3 minute.Additional details, this adverse event information was reported on (b)(6) 2017 the consumer reported she accidently swallowed the polident 3-minute 120ct solution.She asked was she going to be okay.She called poison control, and they said she might get sick.She did feel a little queasy, but she felt better now.The consumer did not see a doctor regarding this issue.

• Brand Name: POLIDENT 3 MINUTE
• 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: 6756334
• MDR Text Key: 81470502
• Report Number: 1020379-2017-00058
• 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: 07/28/2017

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
• Device Lot Number: MP1312
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/01/2017
• 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: 74 YR