MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for EDM manufactured by Medtronic Ps Medical, Inc..
[101176380]
Patient Sequence No: 1, Text Type: N, H10
[101176381]
Medical doctor anesthesiologist was pulling out catheter when she noticed tip had sheared off catheter. Possible user error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7302363 |
| MDR Report Key | 7302363 |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-23 |
| Date of Event | 2017-12-18 |
| Report Date | 2018-02-20 |
| Date Reported to FDA | 2018-02-20 |
| Date Reported to Mfgr | 2018-02-20 |
| Date Added to Maude | 2018-02-28 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | EDM |
| Generic Name | INTRACEREBRAL INFUSION/DRAINAGE CATHETER, SHORT-TERM |
| Product Code | PCB |
| Date Received | 2018-02-28 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | D73020 |
| Device Expiration Date | 2019-11-30 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PS MEDICAL, INC. |
| Manufacturer Address | 710 MEDTRONIC PARKWAY MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-28 |