MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-25 for JAPANESE 5 MINUTE POLIDENT (ENZYME WITH SODIUM PERCARBONATE)-MFC51009 manufactured by Block Drug Co., Inc..
[139804972]
1020379-2019-00015 is associated with argus case (b)(4). Japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009 is marketed in the us as polident tablets.
Patient Sequence No: 1, Text Type: N, H10
[139804973]
Suicide attempt. Case description: this case was reported by a consumer via other manufacturer and described the occurrence of suicide attempt in a (b)(6) year-old female patient who received denture cleanser (japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009) tablet for an unknown indication. On an unknown date, the patient started japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009 (oral) 11 dosage form(s) at an unknown frequency. On an unknown date, an unknown time after starting japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009, the patient experienced suicide attempt (serious criteria gsk medically significant) and intentional product misuse. The action taken with japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009 was unknown. On an unknown date, the outcome of the suicide attempt and intentional product misuse were unknown. It was unknown if the reporter considered the suicide attempt to be related to japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009. Additional details: the patient intentionally ingested 11 tablets of japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009 to attempt suicide. As of the report, no symptom was noted. No further information is expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00015 |
| MDR Report Key | 8449445 |
| Date Received | 2019-03-25 |
| Date of Report | 2019-03-05 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-03-25 |
| 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 | 0 |
| Brand Name | JAPANESE 5 MINUTE POLIDENT (ENZYME WITH SODIUM PERCARBONATE)-MFC51009 |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-03-25 |
| 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 | 2019-03-25 |