MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for SAPPHIRE EMAR manufactured by Unk.
[140892541]
On xx-xx-2019 at approx 1030, i was informed by xx, rn that youth xx had reported to her that he was not given his med (keppra 500mg) last night. Xx, rn reported to this writer that the youth's keppra 500mg 1 tab po bid order did not show up in sapphire emar during the 0730 medpass. However, she was aware of his medication orders and gave him his morning dose. Medical administered to or used by the pt: no. Outcome: however, she was aware of his medication orders and gave him his morning dose. Pt counseling provided: unk. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085513 |
| MDR Report Key | 8474042 |
| Date Received | 2019-04-01 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-01-01 |
| Date Added to Maude | 2019-04-02 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SAPPHIRE EMAR |
| Generic Name | MEDICAL DEVICE DATA SYSTEM |
| Product Code | OUG |
| Date Received | 2019-04-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-01 |