MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-05-29 for COREGA TABS 3 MINUTEN manufactured by Block Drug Co., Inc..
[146347581]
Argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146347582]
Breast cancer. Left denture in a glass with expired product (expired device used). Left denture in a glass with expired product (wrong technique in device usage process). Case description: this case was reported by a consumer via call center representative and described the occurrence of breast cancer in a (b)(6) year-old female patient who received denture cleanser (corega tabs 3 minuten) tablet (batch number mh071524a, expiry date 31st august 2017) for drug use for unknown indication. In 2016, the patient started corega tabs 3 minuten at an unknown dose and frequency. On an unknown date, an unknown time after starting corega tabs 3 minuten, the patient experienced breast cancer (serious criteria gsk medically significant), expired device used and wrong technique in device usage process. The action taken with corega tabs 3 minuten was unknown. On an unknown date, the outcome of the breast cancer, expired device used and wrong technique in device usage process were unknown. It was unknown if the reporter considered the breast cancer, expired device used and wrong technique in device usage process to be related to corega tabs 3 minuten. (b)(4). Additional details: consumer was a buyer of corega tablets and the thing was that she went through a long process of an illness and she had bought a box of corega tablets and it expired in 2017. It was 23 tablets. On reporting day she putted the denture in with the product. She bought them, but then she left them because she had an illness, breast cancer. She would take out her denture, she did not because she wanted to buy something. She wanted to have a cleaner denture but she was retired. She was going to put it in a glass and see what happened but now she was scared that there could be a contraindication when she putted her dentures on. Next month she had surgery done for a malpraxis. The consumer mentioned that she started to use corega tablets in 2016 and at the same time, that year, she stopped using them due to breast cancer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00030 |
| MDR Report Key | 8649390 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-05-29 |
| Date of Report | 2019-05-14 |
| Date Mfgr Received | 2019-05-14 |
| Date Added to Maude | 2019-05-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 TABS 3 MINUTEN |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-05-29 |
| Lot Number | MH071524A |
| Device Expiration Date | 2017-08-31 |
| 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 | 2019-05-29 |