MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-08 for AFFIRM PRONE BIOPSY SYSTEM, 3D PBX-SYS-AFFIRM-3D manufactured by Hologic, Inc.
[145541559]
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
[145541560]
It was reported that "needle hit array and now causing artifact. " additional information obtained noted that during a breast biopsy when the needle fired an odd sound was heard and the patient had some discomfort. The patient was numbed more and the biopsy was completed successfully. No medical intervention was needed. A field engineer was dispatched to the site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2019-00049 |
| MDR Report Key | 8590336 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-18 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-04-18 |
| Device Manufacturer Date | 2019-01-03 |
| Date Added to Maude | 2019-05-08 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | AFFIRM PRONE BIOPSY SYSTEM, 3D |
| Generic Name | BREAST BIOPSY SYSTEM |
| Product Code | IZH |
| Date Received | 2019-05-08 |
| Model Number | PBX-SYS-AFFIRM-3D |
| Catalog Number | PBX-SYS-AFFIRM-3D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-08 |