MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-10 for LUNAR PRODIGY manufactured by Ge Healthcare.
[3971577]
It was reported that while the scan arm of a lunar prodigy system was positioning going from a spine exam to a femur exam, the arm came into contact with the patient left thigh. The technologist immediately looked at the patients leg and observed bruising. The patient also sustained meniscus damage on the knee.
Patient Sequence No: 1, Text Type: D, B5
[11465558]
Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124823-2013-00026 |
| MDR Report Key | 3525518 |
| Report Source | 05,06 |
| Date Received | 2013-12-10 |
| Date of Report | 2013-11-11 |
| Date of Event | 2013-11-05 |
| Date Mfgr Received | 2013-11-11 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2013-12-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY SONSALLA |
| Manufacturer Street | 3000 N GRANDVIEW BLVD |
| Manufacturer City | MILWAUKEE WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE HEALTHCARE |
| Manufacturer City | MILWAUKEE WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUNAR PRODIGY |
| Generic Name | DENSITOMETER, BONE |
| Product Code | KGI |
| Date Received | 2013-12-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | MILWAUKEE WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-10 |