MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-05-08 for POLIDENT ACTIVE OXYGEN manufactured by Block Drug Co., Inc..
[144404609]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[144404610]
Accidental ingestion [accidental device ingestion]. Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a (b)(6) year-old female patient who received denture cleanser (polident active oxygen) tablet (batch number ke3c, expiry date 30th september 2021) for product used for unknown indication. On an unknown date, the patient started polident active oxygen. On (b)(6) 2019, an unknown time after starting polident active oxygen, the patient experienced accidental device ingestion (serious criteria gsk medically significant). The action taken with polident active oxygen was unknown. On an unknown date, the outcome of the accidental device ingestion was unknown. The reporter considered the accidental device ingestion to be related to polident active oxygen. Additional details: a consumer called on behalf of his wife. The patient had ingested a tablet of polident by accident in the morning of (b)(6) 2019. They had already contacted the anti-poisons information centre and their physician and were informed to ingest plenty of milk, water, juices and liquids.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00025 |
| MDR Report Key | 8590500 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-05-08 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-05-08 |
| 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 ACTIVE OXYGEN |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-05-08 |
| Lot Number | KE3C |
| 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 | 2019-05-08 |