MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-04-12 for JAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED) manufactured by Block Drug Co., Inc..
[141733461]
Argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141733462]
Suicide attempt. Case description: this case was reported by a non-health professional via call center representative and described the occurrence of suicide attempt in a (b)(6) female patient who received denture cleanser (japanese polident for partials (polident for partials with taed)) tablet (batch number nl4f, expiry date unknown) for an unknown indication. On an unknown date, the patient started japanese polident for partials (polident for partials with taed) (oral) 3 dosage form(s) single dose (3 dosage form(s) daily). On an unknown date, an unknown time after starting japanese polident for partials (polident for partials with taed), the patient experienced suicide attempt (serious criteria gsk medically significant) and intentional product misuse. 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 polident for partials (polident for partials with taed). Additional details: the patient ate 3 tablets of japanese polident for partials (polident for partials with taed) to attempt suicide. No abnormality was noted as of the report. No further information is expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00020 |
| MDR Report Key | 8508320 |
| Report Source | FOREIGN |
| Date Received | 2019-04-12 |
| Date of Report | 2019-03-27 |
| Date Mfgr Received | 2019-03-27 |
| 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 | 0 |
| 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 | JAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED) |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-04-12 |
| 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 |