MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for KIWIPRO COMPLETE VACUUM DELIVERY SYSTEM VAC-6000S manufactured by Clinical Innovations, Llc..
| Report Number | MW5090365 |
| MDR Report Key | 9192318 |
| Date Received | 2019-10-11 |
| Date of Report | 2019-10-09 |
| Date of Event | 2019-09-25 |
| Date Added to Maude | 2019-10-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KIWIPRO COMPLETE VACUUM DELIVERY SYSTEM |
| Generic Name | EXTRACTOR, VACUUM, FETAL |
| Product Code | HDB |
| Date Received | 2019-10-11 |
| Catalog Number | VAC-6000S |
| Lot Number | 190437 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS, LLC. |
| Manufacturer Address | MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-11 |