MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-31 for POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS manufactured by Block Drug Co., Inc..
[125602012]
This report is associated with (b)(4), polident overnight denture cleanser tablets.
Patient Sequence No: 1, Text Type: N, H10
[125602013]
I took a drink to swallow the pill and i drank the polident [accidental device ingestion] i just have itching but i always get itchy [pruritus].. 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 denture cleanser (polident overnight denture cleanser tablets) tablet (batch number unknown, expiry date unknown) for denture wearer. On an unknown date, the patient started polident overnight denture cleanser tablets. On (b)(6) 2018, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and pruritus. The action taken with polident overnight denture cleanser tablets was unknown. On an unknown date, the outcome of the accidental device ingestion and pruritus were unknown. It was unknown if the reporter considered the accidental device ingestion and pruritus to be related to polident overnight denture cleanser tablets. Additional information, adverse event information was received via call on 25 october 2018. Consumer reported that, "i did something really stupid. I uh, it was dark and i took a pill and i had my dentures in with the polident. I took a drink to swallow the pill and i drank the polident. I just have itching but i always get itchy. I do not have the box i think it is the 40 ct. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2018-00065 |
| MDR Report Key | 8023065 |
| Report Source | CONSUMER |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-10-24 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-10-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2018-10-31 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLOCK DRUG CO., INC. |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-31 |