MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-07 for BREAST BIOPSY / LOCALIZATION TRAY manufactured by Hologic, Inc..
[173912871]
The screen on the mammo unit was down, rebooted and tested equipment, seemed to be working, started patient and equipment went down after 2nd image. Patient will be called to come back in when equipment is up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9557494 |
| MDR Report Key | 9557494 |
| Date Received | 2020-01-07 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-10-14 |
| Report Date | 2019-12-17 |
| Date Reported to FDA | 2019-12-17 |
| Date Reported to Mfgr | 2020-01-07 |
| Date Added to Maude | 2020-01-07 |
| 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 | BREAST BIOPSY / LOCALIZATION TRAY |
| Product Code | PXP |
| Date Received | 2020-01-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |