MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-30 for POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS manufactured by Block Drug Co., Inc..
[134594278]
1020379-2019-00004 is associated with argus case (b)(4), polident overnight denture cleanser tablets.
Patient Sequence No: 1, Text Type: N, H10
[134594279]
My sister took her plate out of the solution but did not rinse off the solution. She feels that it's closing up her throat [accidental device ingestion]. She feels that it's closing up her throat, but she is having throat problems anyway [throat constriction]. It was expired [expired device used]. My sister took her plate out of the solution but did not rinse off the solution [wrong technique in device usage process]. Case description: 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 mj221524b, expiry date 31st october 2018) 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 throat constriction, expired device used and wrong technique in device usage process. On an unknown date, the patient experienced accidental device ingestion (serious criteria gsk medically significant). The action taken with polident overnight denture cleanser tablets was unknown. On an unknown date, the outcome of the accidental device ingestion, expired device used and wrong technique in device usage process were unknown and the outcome of the throat constriction was recovered/resolved. It was unknown if the reporter considered the accidental device ingestion, expired device used and wrong technique in device usage process to be related to polident overnight denture cleanser tablets. The reporter considered the throat constriction to be related to polident overnight denture cleanser tablets. Additional information: adverse event information was received via email on (b)(6) 2019. The consumer reported that, "the polident package says if swallowed, you could have allergic reactions. Do they mean swallow the actual tablet or the solution that it is in? My sister took her plate out of the solution but did not rinse off the solution. She feels that it's closing up her throat, but she is having throat problems anyway. This was a sample from her dentist. It was expired. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00004 |
| MDR Report Key | 8289664 |
| Date Received | 2019-01-30 |
| Date of Report | 2019-01-22 |
| Date Mfgr Received | 2019-01-22 |
| Date Added to Maude | 2019-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 |
| 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 | 0 |
| Brand Name | POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-01-30 |
| Lot Number | MJ221524B |
| Device Expiration Date | 2018-10-31 |
| 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 | 2019-01-30 |