MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-03-05 for COREGA TABS manufactured by Block Drug Co, Inc..
[137811074]
Mdr: 1020379-2019-00014 is associated with argus case (b)(4), corega tabs. Corega tabs is marketed as polident tablets in the us.
Patient Sequence No: 1, Text Type: N, H10
[137811075]
Accidentally a quarter of a tab ingested (accidental device ingestion by a child). Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion by a child in a (b)(6) female patient who received denture cleanser (corega tabs) tablet for drug use for unknown indication. On an unknown date, the patient started corega tabs. On an unknown date, an unknown time after starting corega tabs, the patient experienced accidental device ingestion by a child (serious criteria gsk medically significant). The action taken with corega tabs was unknown. On an unknown date, the outcome of the accidental device ingestion by a child was not reported. It was unknown if the reporter considered the accidental device ingestion by a child to be related to corega tabs. Additional details: the patient's father reported that, accidentally the patient (one and half year old) ingested a quarter of a tab. No adverse reaction was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00014 |
| MDR Report Key | 8389945 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-03-05 |
| Date of Report | 2019-02-25 |
| Date Mfgr Received | 2019-02-25 |
| Date Added to Maude | 2019-03-05 |
| 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 | 3 |
| Brand Name | COREGA TABS |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-03-05 |
| 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 | 2019-03-05 |