MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-08 for PERCUST ARTHROGRAM TRAY manufactured by Unk.
[69962246]
Pt underwent mr arthrogram on (b)(6) 2017 with right hip injected with omnipaque 300 ((b)(4)). Ge healthcare (b)(4) plus naropin 0. 5% (b)(4) app fresenius (b)(4); plus, third agent magnevist ndc (b)(4) bayer lot # 53540d and utilizing the percust arthrogram tray (b)(4) exp june 2019 and has been admitted to (b)(4) medical center with a septic hip on (b)(6) 2017. Dose or amount: 10 ml, frequency: once, route: intra-articular, 5 ml, once, intra-articular.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068415 |
| MDR Report Key | 6399195 |
| Date Received | 2017-03-08 |
| Date of Report | 2017-03-08 |
| Date of Event | 2017-02-28 |
| Date Added to Maude | 2017-03-13 |
| 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 | PERCUST ARTHROGRAM TRAY |
| Generic Name | ARTHROGRAM TRAY |
| Product Code | OII |
| Date Received | 2017-03-08 |
| Lot Number | 1630-17 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 3 | 1. Hospitalization; 2. Other | 2017-03-08 |