MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-05-31 for KIWI OMNICUP VAC-6000ME manufactured by Clinical Innovations.
| Report Number | 1722684-2019-00011 |
| MDR Report Key | 8661093 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-05-31 |
| Date of Report | 2019-07-16 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-07-15 |
| Date Added to Maude | 2019-05-31 |
| 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 | PHARMACIST |
| 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 |
| Product Code | HDB |
| Date Received | 2019-05-31 |
| Returned To Mfg | 2019-07-09 |
| Model Number | VAC-6000ME |
| Lot Number | 181003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-31 |