MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-09-04 for VENUE R2 manufactured by Seeh10.
| Report Number | 3005860720-2019-00002 |
| MDR Report Key | 8961088 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-09-04 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-07-24 |
| Date Mfgr Received | 2019-08-05 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-09-04 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOSEPH TAMBLYN |
| Manufacturer Street | 9900 INNOVATION DRIVE MAIL DROP RP-2130 |
| Manufacturer City | WAUWATOSA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENUE R2 |
| Generic Name | DIAGNOSTIC ULTRASOUND SYSTEM |
| Product Code | IYN |
| Date Received | 2019-09-04 |
| Lot Number | VEB002237 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEEH10 |
| Manufacturer Address | 9900 INNOVATION DRIVE WAUWATOSA, WI 532264856 US 532264856 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-09-04 |