MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-11 for POLIDENT manufactured by Block Drug Co., Inc..
[135884661]
Report# 1020379-2019-00009 is associated with argus case (b)(4), polident.
Patient Sequence No: 1, Text Type: N, H10
[135884662]
I have a patient who eat by accident the polident denture cleanser (accidental device ingestion). Case description: this case was reported by a dentist and described the occurrence of accidental device ingestion in a female patient who received denture cleanser (polident) unknown (batch number unk, expiry date unknown) for product used for unknown indication. On an unknown date, the patient started polident. On an unknown date, an unknown time after starting polident, 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. Adverse event information was received via call on 04 february 2019. The consumer reported that, "i have a patient who eat by accident the polident denture cleanser. She called poison control already. They said drink water. Eat cracker. It happens pretty often i guess. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00009 |
| MDR Report Key | 8326216 |
| Date Received | 2019-02-11 |
| Date of Report | 2019-02-04 |
| Date Mfgr Received | 2019-02-04 |
| Date Added to Maude | 2019-02-11 |
| 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 |
| Reporter Occupation | DENTIST |
| 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 |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-02-11 |
| Lot Number | UNKNOWN |
| 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 | 2019-02-11 |