MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-18 for KIT, NEEDLE, BIOPSY manufactured by .
[89692130]
Patient Sequence No: 1, Text Type: N, H10
[89692131]
During right partial mastectomy and right sentinal node biopsy, the tru node wand would not register with the tru node device. No patient harm. Device sent back to manufacturer for follow up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6958691 |
| MDR Report Key | 6958691 |
| Date Received | 2017-10-18 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-08-16 |
| Report Date | 2017-09-20 |
| Date Reported to FDA | 2017-09-20 |
| Date Reported to Mfgr | 2017-09-20 |
| Date Added to Maude | 2017-10-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Generic Name | KIT, NEEDLE, BIOPSY |
| Product Code | POZ |
| Date Received | 2017-10-18 |
| Lot Number | 120716 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-18 |