MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-04-26 for LOGIQ E9 ULOE9Y manufactured by See H10.
[143239656]
No report of patient involvement, this is a user injury. Legal manufacturer name is ge medical systems ultrasound & primary care diagnostics llc. Device manufactured in 2013, udi not required. Ge is currently attempting an investigation of the event.
Patient Sequence No: 1, Text Type: N, H10
[143239657]
Ge healthcare internal counsel received notice of a lawsuit from someone who alleges she was a former user of the ultrasound device. The plaintiff in the lawsuit alleges that on or about (b)(6) 2017 while physically raising the keyboard and monitor on the ultrasound, she suffered severe and permanent injuries to her right shoulder and scapular muscle. No further details have been provided to ge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005860720-2019-00001 |
| MDR Report Key | 8554991 |
| Report Source | OTHER |
| Date Received | 2019-04-26 |
| Date of Report | 2019-09-03 |
| Date of Event | 2017-01-28 |
| Date Mfgr Received | 2019-03-29 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-04-26 |
| 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 | JOSEPH TAMBLYN |
| Manufacturer Street | MAIL DROP: RP-2130 9900 W INNOVATION DRIVE |
| Manufacturer City | WAUWATOSA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOGIQ E9 |
| Generic Name | DIAGNOSTIC ULTRASOUND SYSTEM |
| Product Code | IYN |
| Date Received | 2019-04-26 |
| Model Number | ULOE9Y |
| Lot Number | 123630US6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEE H10 |
| Manufacturer Address | 9900 INNOVATION DRIVE WAUWATOSA, WI 532264856 US 532264856 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-04-26 |