MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-09 for MARGINPROBE manufactured by Dune Medical Devices Inc..
[37733806]
Patient Sequence No: 1, Text Type: N, H10
[37733807]
Nurses connected the margin probe to the machine as instructed by the surgeon. Initially it seemed to work, and then the screen showed "failure". Manufacturer response for dunn margin probe x 2, dunn (per site reporter): the rep was here to check the machine and see if this was the issue or the hand pieces and if the machine was working correctly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5418676 |
| MDR Report Key | 5418676 |
| Date Received | 2016-02-09 |
| Date of Report | 2016-01-18 |
| Date of Event | 2015-11-05 |
| Report Date | 2016-01-18 |
| Date Reported to FDA | 2016-01-18 |
| Date Reported to Mfgr | 2016-01-18 |
| Date Added to Maude | 2016-02-09 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | MARGINPROBE |
| Generic Name | DIAGNOSTIC LOW ELECTRIC FIELD |
| Product Code | OEE |
| Date Received | 2016-02-09 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUNE MEDICAL DEVICES INC. |
| Manufacturer Address | 43 LEOPARD ROAD, SUITE 302 PAOLI, PA 19301 US 19301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-09 |