MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-05-14 for COREGA TABLETS manufactured by Block Drug Co., Inc..
[144974677]
Argus case id: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[144974678]
Took half a tablet of corega (accidental device ingestion). Burned him a little bit (burning mouth). Case description: this case was reported by a other health professional via call center representative and described the occurrence of accidental device ingestion in a male patient who received denture cleanser (corega tablets) tablet for drug use for unknown indication. On an unknown date, the patient started corega tablets. On an unknown date, an unknown time after starting corega tablets, the patient experienced accidental device ingestion (serious criteria (b)(4) medically significant) and burning mouth. The action taken with corega tablets was unknown. On an unknown date, the outcome of the accidental device ingestion and burning mouth were unknown. It was unknown if the reporter considered the accidental device ingestion and burning mouth to be related to corega tablets. This report is made by (b)(4) without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details, the reporter informed that the patient accidentally took half a tablet of corega, the cleaning tablets for the prosthesis, and it burned him a little bit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00026 |
| MDR Report Key | 8607367 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-14 |
| Date of Report | 2019-04-24 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-14 |
| 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 | COREGA TABLETS |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-05-14 |
| 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 | 2019-05-14 |