MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-04 for MEDICAL COMPUTERS AND SOFTWARE manufactured by Unk.
[137949334]
Patient has been taking tozal, an omega 3 based dietary supplement, instead of rheumate, a b-vitamin supplement from xx-x-2017 until x-xx-2017 (5 months after). We filled tozal as a substitute for the rheumate. The tozal was listed as a substitute for the rheumate in our computer system. The prescriber caught the error and informed the patient. She informed us on x-xx-2017. We immediately removed the option to select tozal as equivalent in our computer system and contacted the software vendor to let them know. They will be checking their system to ensure this med error was an isolated incident within our system. (b)(6). (b)(4). Medication administered to or used by the patient: no. Relevant materials provided: none.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084626 |
| MDR Report Key | 8389839 |
| Date Received | 2019-03-04 |
| Date of Report | 2018-04-23 |
| Date Added to Maude | 2019-03-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDICAL COMPUTERS AND SOFTWARE |
| Generic Name | MEDICAL COMPUTERS AND SOFTWARE |
| Product Code | LNX |
| Date Received | 2019-03-04 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-04 |