MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-17 for 3DIMENSIONS 3DM-SYS-INTL3D manufactured by Hologic, Inc.
[183887511]
As of today the investigation is still in process and a follow up will be filed as needed.
Patient Sequence No: 1, Text Type: N, H10
[183887512]
It was reported that the estop is not being recognized by the system when pressed. No injury reported. Additional information obtained reported that the issue was found by an applications trainer performing routine checks during initial training. A field engineer was dispatched to the site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2020-00042 |
| MDR Report Key | 9844680 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 7318491 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3DIMENSIONS |
| Generic Name | MAMMOGRAPHY SYSTEM |
| Product Code | OTE |
| Date Received | 2020-03-17 |
| Model Number | 3DM-SYS-INTL3D |
| Catalog Number | 3DM-SYS-INTL3D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 36 & 37 APPLE RIDGE ROAD DANBURY, CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |