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

Lot Number MB0117248

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Headache (1880); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

He did not swallow a tablet, might be just some of the solution.He did have a slight headache.He just did not feel well.Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) male patient who received double salt denture cleanser (polident overnight denture cleanser tablets) tablet (batch number mb0117248, expiry date unknown) for dental care.On an unknown date, the patient started polident overnight denture cleanser tablets.On (b)(6) 2017, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced headache.On an unknown date, the patient experienced accidental device ingestion (serious criteria gsk medically significant), feeling unwell, wrong technique in drug usage process, wrong technique in device usage process and accidental ingestion of drug.Polident overnight denture cleanser tablets was continued with no change.On an unknown date, the outcome of the accidental device ingestion, wrong technique in drug usage process, wrong technique in device usage process and accidental ingestion of drug were unknown and the outcome of the headache and feeling unwell were not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion, headache and feeling unwell to be related to polident overnight denture cleanser tablets.Additional information: adverse event information was received on 06 april 2017.Consumer reported that, he did have a slight headache.The headache started a few hours after he rinsed his dentures and put it in his mouth.He started using the polident tablets, just started using them now, within the month.He still had the headache.He just did not feel well, even before he used the polident.He did not rinse it thoroughly.His doctor was knowing about his headaches.He did not swallow a tablet, might be just some of the solution.He did rinse it thoroughly just now and put it in his mouth.It was just a bad headache.

• Brand Name: POLIDENT OVERNIGHT 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: 6499685
• MDR Text Key: 73022452
• Report Number: 1020379-2017-00031
• 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: 04/06/2017

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: MB0117248
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 04/18/2017
• 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: 84 YR