MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-12 for POLIDENT DENTURE CLEANSER TABLETS manufactured by Block Drug Co., Inc..
[141742189]
Argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141742190]
He ate and swallowed 3 polident tablets last night. [accidental device ingestion]. Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a male patient who received denture cleanser (polident denture cleanser tablets) tablet (batch number unknown, expiry date unknown) for product used for unknown indication. Concurrent medical conditions included alzheimer's disease. On (b)(6) 2019, the patient started polident denture cleanser tablets. On (b)(6) 2019, an unknown time after starting polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant). On an unknown date, the outcome of the accidental device ingestion was unknown. It was unknown if the reporter considered the accidental device ingestion to be related to polident denture cleanser tablets. This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. Additional information: adverse event information was received via call on (b)(6) 2019. The consumer reported that "my father-in-law has alzheimer's and he ate and swallowed 3 polident tablets last night. ".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00019 |
| MDR Report Key | 8508336 |
| Report Source | CONSUMER |
| Date Received | 2019-04-12 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-03-24 |
| Date Mfgr Received | 2019-03-25 |
| Date Added to Maude | 2019-04-12 |
| 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 RESEARCH TRIANGLE PARK |
| Manufacturer City | 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 DENTURE CLEANSER TABLETS |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-04-12 |
| 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 | 2019-04-12 |