MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-05-14 for COREGA TABLETS manufactured by Block Drug Co., Inc..
[144974788]
Argus case id (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[144974789]
Accidental intake (medication error without harm) [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) female patient who received denture cleanser (corega tablets) tablet for denture wearer. 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 gsk medically significant). The action taken with corega 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 tablets. Additional details: a consumer's relative reported that the patient had used corega cleanser tablets for cleaning her prosthesis and on (b)(6) 2019 she drank the glass with the water where corega was dissolved. She had not presented any adverse events. She drank water and a glass of milk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00027 |
| MDR Report Key | 8607362 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-05-14 |
| Date of Report | 2019-04-26 |
| Date Mfgr Received | 2019-04-26 |
| 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 |