MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-10 for POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS manufactured by Block Drug Co., Inc..
[141439871]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141439872]
My wife took a swallow of the solution. I use the solution but she woke up 4am and drank solution. [accidental device ingestion]. Little irritation on her throat [throat irritation]. This case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6)-year-old female patient who received denture cleanser (polident overnight denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication. On an unknown date, the patient started polident overnight denture cleanser tablets. On (b)(6) 2019, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and throat irritation. The action taken with polident overnight denture cleanser tablets was unknown. On (b)(6) 2019, the outcome of the throat irritation was recovered/resolved. On an unknown date, the outcome of the accidental device ingestion was unknown. It was unknown if the reporter considered the accidental device ingestion and throat irritation to be related to polident overnight denture cleanser tablets. Additional information, adverse event information was received via call on (b)(6) 2019. The patient husband called and reported that, "my wife took a swallow of the solution. I use the solution but she woke up 4am and drank solution. Are there any bad side effects? She is okay but just a little irritation on her throat. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00021 |
| MDR Report Key | 8498997 |
| Report Source | CONSUMER |
| Date Received | 2019-04-10 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-03-29 |
| Date Mfgr Received | 2019-03-29 |
| Date Added to Maude | 2019-04-10 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 OVERNIGHT DENTURE CLEANSER TABLETS |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-04-10 |
| Lot Number | UNK |
| 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 | 2019-04-10 |