MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-04-10 for COREGA TABS manufactured by Block Drug Co., Inc..
[141440088]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141440089]
Consumer accidentally took one tab of corega [accidental device ingestion]: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a male patient who received denture cleanser (corega tabs) tablet for dental prosthesis user. 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 (serious criteria gsk medically significant). The action taken with corega tabs 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 tabs. Additional details: the consumer accidentally took one tab of corega, used for dental prosthesis cleaning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00018 |
| MDR Report Key | 8498998 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-04-10 |
| Date of Report | 2019-03-19 |
| Date Mfgr Received | 2019-06-04 |
| Date Added to Maude | 2019-04-10 |
| 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 TABS |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-04-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| 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 | 2019-04-10 |