MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-10-24 for SANDHILL SCIENTIFIC INSIGHT ULTIMA H12R-2000 manufactured by Diversatek Healthcare.
| Report Number | 2183446-2019-00002 |
| MDR Report Key | 9234865 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-10-24 |
| Date of Report | 2019-08-20 |
| Date of Event | 2019-06-11 |
| Date Mfgr Received | 2019-07-02 |
| Date Added to Maude | 2019-10-24 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA BOLL |
| Manufacturer Street | 9150 COMMERCE CENTER CIRCLE SUITE 500 |
| Manufacturer City | HILGHLANDS RANCH, |
| Manufacturer G1 | DIVERSATEK HEALTHCARE |
| Manufacturer Street | 9150 COMMERCE CENTER CIRCLE SUITE 500 |
| Manufacturer City | HIGHLANDS RANCH CO 80129 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80129 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SANDHILL SCIENTIFIC INSIGHT ULTIMA |
| Generic Name | GASTROINTETINAL MOTILITY MONITORING SYSTEM |
| Product Code | FFX |
| Date Received | 2019-10-24 |
| Model Number | H12R-2000 |
| Catalog Number | H12R-2000 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIVERSATEK HEALTHCARE |
| Manufacturer Address | 9150 COMMERCE CENTER CIRCLE SUITE 500 HIGHLANDS RANCH CO 80129 US 80129 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-24 |