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

Device Problem Off-Label Use (1494)

Patient Problems Vomiting (2144); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Report # 1020379-2016-00069 is associated with (b)(4), polident denture cleanser tablets.

Event Description

He was going to take an alka-selzer tablet and he picked up his polident instead / mindlessly put it in the glass of water and drank it [accidental device ingestion]; spit it and made himself vomit [vomiting]; she said he did not feel well [feeling unwell].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 denture cleanser tablets) tablet (batch number unk, expiry date unknown) for dental cleaning.On (b)(6) 2016, the patient started polident denture cleanser tablets.On (b)(6) 2016, immediately after starting polident denture cleanser tablets, the patient experienced vomiting.On an unknown date, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), feeling unwell and accidental ingestion of drug.Polident denture cleanser tablets was discontinued (dechallenge was unknown).On an unknown date, the outcome of the accidental device ingestion and feeling unwell were unknown and the outcome of the vomiting and accidental ingestion of drug were not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion and feeling unwell to be related to polident denture cleanser tablets.The reporter considered the vomiting to be related to polident denture cleanser tablets.Additional details, the adverse event information was received on 05 december 2016.The consumer reported that he was going to take an alka-selzer tablet and he picked up his polident denture cleanser tablets instead, and mindlessly put it in the glass of water and drank it.Immediately, consumer realized what he had done and spit it and made himself vomit.The consumer then called and ask what should he do.He gave phone to his wife while he spoke to poison control, and after spoke with him for a brief moment, asking for his information, and what he should do next.He handed phone to wife, and she said he did not feel well.

• 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: 6154452
• MDR Text Key: 61785444
• Report Number: 1020379-2016-00069
• 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: 12/05/2016

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: 12/05/2016
• Initial Date FDA Received: 12/08/2016
• 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