MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-08 for HOLOGIC DISCOVERY manufactured by Hologic Inc.
[37628504]
Patient Sequence No: 1, Text Type: N, H10
[37628525]
When moving the dxa arm into position the arm jerked. The machine and exam were stopped. Patient rescheduled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5415855 |
| MDR Report Key | 5415855 |
| Date Received | 2016-02-08 |
| Date of Report | 2016-01-20 |
| Date of Event | 2016-01-11 |
| Report Date | 2016-01-20 |
| Date Reported to FDA | 2016-01-20 |
| Date Reported to Mfgr | 2016-01-20 |
| Date Added to Maude | 2016-02-08 |
| 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 |
| 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 | HOLOGIC DISCOVERY |
| Generic Name | DENSITOMETER, BONE |
| Product Code | KGI |
| Date Received | 2016-02-08 |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INC |
| Manufacturer Address | 35 CROSBY DRIVE BEDFORD, MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-08 |