MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-05-17 for POLIDENT DENTURE CLEANSER FRESH ACTIVE EXPRESS 3-MINUTE manufactured by Block Drug Co., Inc..
[145370456]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145370477]
Exposure to product [accidental device ingestion]. Case description: this case was reported by a pharmacist via other and described the occurrence of accidental exposure to product related to device use in a patient who received denture cleanser (polident denture cleanser fresh active express 3-minute) tablet for product used for unknown indication. On an unknown date, the patient started polident denture cleanser fresh active express 3-minute at an unknown dose and frequency. On an unknown date, an unknown time after starting polident denture cleanser fresh active express 3-minute, the patient experienced accidental exposure to product related to device use. On an unknown date, the outcome of the accidental exposure to product related to device use was unknown. It was unknown if the reporter considered the accidental exposure to product related to device use to be related to polident denture cleanser fresh active express 3-minute. Additional details: case was reported by a poison control centre. The case was of exposure to polident denture cleanser fresh active express 3-minute. Follow up information was received on 06 may 2019 from pharmacist: (b)(6)-year-old male patient received denture cleanser (polident denture cleanser fresh active express 3-minute) tablet. Concurrent medical conditions included dementia. On (b)(6) 2019, the patient started polident denture cleanser fresh active express 3-minute (oral) at an unknown dose. On (b)(6) 2019, less than a day after starting polident denture cleanser fresh active express 3-minute, 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 fresh active express 3-minute. The patient demographic details were updated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00029 |
| MDR Report Key | 8619362 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-17 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-03-23 |
| Date Mfgr Received | 2019-05-06 |
| Date Added to Maude | 2019-05-17 |
| 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 FRESH ACTIVE EXPRESS 3-MINUTE |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-05-17 |
| 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 | 2019-05-17 |