MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-10-19 for USYSTEMS INVENIA GEN 2 USYST2 manufactured by U-systems, Inc..
[124332879]
(b)(4). The facility believes the patient was scanned with the correct compression settings and scan techniques, and they do not believe the patient was improperly scanned nor do they believe the ultrasound scanner (invenia abus) malfunctioned. An investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[124332880]
During a breast scan the patient complained of rib pain. The scan was completed, and the patient was sent home. A couple days later the patient called back stating the pain did not subside, so she went to her physician who ordered an xray, and the radiology report was supplied to (b)(6) hospital. Within the radiology report it was noted that ribs 11&12 were displaced, however they could not confirm the date of the injury and whether there was a pre-existing rib injury. The patient alleges the ultrasound breast scan is the cause of her broken ribs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005860720-2018-00003 |
| MDR Report Key | 7984662 |
| Report Source | USER FACILITY |
| Date Received | 2018-10-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-09-08 |
| Date Mfgr Received | 2018-09-26 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2018-10-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOSEPH TAMBLYN |
| Manufacturer Street | 9900 W. INNOVATION DR. MAIL DROP: RP-2138 |
| Manufacturer City | WAUWATOSA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | USYSTEMS INVENIA GEN 2 |
| Generic Name | AUTOMATED BREAST ULTRASOUND |
| Product Code | PAA |
| Date Received | 2018-10-19 |
| Model Number | USYST2 |
| Lot Number | INVS1700072 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | U-SYSTEMS, INC. |
| Manufacturer Address | 9900 W. INNOVATION DRIVE WAUWATOSA, WI 532264856 US 532264856 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-19 |