MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-02-28 for COREGA DENTURE CLEANSING TABLETS manufactured by Block Drug Co., Inc..
[181482698]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181482699]
Medication error - consumer drank corega tablet [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 patient who received denture cleanser (corega denture cleansing tablets) tablet for drug use for unknown indication. Concurrent medical conditions included alzheimer's disease. On an unknown date, the patient started corega denture cleansing tablets. On an unknown date, an unknown time after starting corega denture cleansing tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant). The action taken with corega denture cleansing tablets was unknown. 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 corega denture cleansing tablets. Additional details: alzheimer patient drank corega tablet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2020-00006 |
| MDR Report Key | 9769409 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-02-28 |
| Date of Report | 2020-01-31 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-28 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 | COREGA DENTURE CLEANSING TABLETS |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2020-02-28 |
| Device Availability | N |
| 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 | 2020-02-28 |