MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-30 for KIWI VACUUM EXTRATOR VAC-6000M manufactured by Clinical Innovations, Llc.
| Report Number | 8949892 |
| MDR Report Key | 8949892 |
| Date Received | 2019-08-30 |
| Date of Report | 2019-07-31 |
| Date of Event | 2019-04-25 |
| Report Date | 2019-07-31 |
| Date Reported to FDA | 2019-07-31 |
| Date Reported to Mfgr | 2019-08-30 |
| Date Added to Maude | 2019-08-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | KIWI VACUUM EXTRATOR |
| Generic Name | EXTRACTOR, VACUUM, FETAL |
| Product Code | HDB |
| Date Received | 2019-08-30 |
| Model Number | VAC-6000M |
| Catalog Number | VAC-6000M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS, LLC |
| Manufacturer Address | 747 W 4170 S MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-30 |