MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-06-25 for KIWI OMNICUP VAC-6000MTE manufactured by Clinical Innovations.
| Report Number | 1722684-2019-00014 |
| MDR Report Key | 8732003 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-06-25 |
| Date of Report | 2019-07-25 |
| Date of Event | 2018-05-20 |
| Date Mfgr Received | 2019-07-25 |
| Date Added to Maude | 2019-06-25 |
| 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 | MS LAURA SMITH |
| Manufacturer Street | 747 W 4170 S |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012667373 |
| Manufacturer G1 | CLINICAL INNOVATIONS |
| Manufacturer Street | 747 W 4170 S |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIWI OMNICUP |
| Generic Name | KIWI VACUUM DELIVERY SYSTEM, OMNICUP WITH TRACTION FORCE INDICATOR |
| Product Code | HDB |
| Date Received | 2019-06-25 |
| Catalog Number | VAC-6000MTE |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS |
| Manufacturer Address | 747 W 4170 S MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-25 |