MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-10 for JON + ALERT manufactured by Medtronic Systems, Inc..
[20328073]
I'm looking to find out if an actively locked/ unlocked, remaindered pull dispensing system should be fda controlled. I have concerns that flaws in the design, if it were not approved by the fda, could result in pt harm (no pills, too many pills, etc).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034908 |
| MDR Report Key | 3677423 |
| Date Received | 2014-03-10 |
| Date of Report | 2014-03-07 |
| Date of Event | 2014-03-07 |
| Date Added to Maude | 2014-03-14 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JON + ALERT |
| Generic Name | JON + ALERT |
| Product Code | NXQ |
| Date Received | 2014-03-10 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SYSTEMS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-10 |