MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-27 for MULTICARE PLATINUM STEREOTACTIC BREAST BIOPSY DEVICE 8-004-0017 manufactured by Hologic, Inc..
[128456834]
Wile performing daily qc on the stereotactic unit, the tech discovered that the needle test was out of limits and the compression paddle lock was broken. Due to this event the patient/exam double stereo scheduled for today was not able to be done and a single score biopsy had to be completed in the ultrasound dept. Patient will possibly have to return on another day to have the stereotactic biopsy done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8105467 |
| MDR Report Key | 8105467 |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-19 |
| Date of Event | 2015-09-24 |
| Report Date | 2018-11-19 |
| Date Reported to FDA | 2018-11-19 |
| Date Reported to Mfgr | 2018-11-27 |
| Date Added to Maude | 2018-11-27 |
| 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 |
| Brand Name | MULTICARE PLATINUM STEREOTACTIC BREAST BIOPSY DEVICE |
| Generic Name | SYSTEM, X-RAY, MAMMOGRAPHIC |
| Product Code | IZH |
| Date Received | 2018-11-27 |
| Model Number | 8-004-0017 |
| Catalog Number | 8-004-0017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-11-27 |