MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-09 for SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D SDM-00001-3D manufactured by Hologic, Inc.
[178760960]
It was reported that the x-ray shield had shattered and needs to be replaced. Additional information was received that reported "when the technologist came back into the room the shield was broken. " no injury reported. The onsite biomedical engineer will be handling the order and replacement of the glass shield.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2020-00004 |
| MDR Report Key | 9568565 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-09 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2019-12-20 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTIN FORNIERI |
| Manufacturer Street | 36 & 37 APPLE RIDGE ROAD |
| Manufacturer City | DANBURY CT 06810 |
| Manufacturer Country | US |
| Manufacturer Postal | 06810 |
| Manufacturer Phone | 2037318491 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D |
| Generic Name | MAMMOGRAPHY SYSTEM |
| Product Code | OTE |
| Date Received | 2020-01-09 |
| Model Number | SDM-00001-3D |
| Catalog Number | SDM-00001-3D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 36 & 37 APPLE RIDGE ROAD DANBURY CT 06810 US 06810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-09 |