MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-07 for KIWI? OMNICUP? VAC-6000M manufactured by Clinical Innovations, Llc.
[178136144]
Upon opening the packaging, it was noted the kiwi vacuum was broken- missing the palm piece which allows to pump the device to build suction. Pictures available if needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681161 |
| MDR Report Key | 9681161 |
| Date Received | 2020-02-07 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-11-27 |
| Report Date | 2020-01-23 |
| Date Reported to FDA | 2020-01-23 |
| Date Reported to Mfgr | 2020-02-07 |
| Date Added to Maude | 2020-02-07 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | KIWI? OMNICUP? |
| Generic Name | EXTRACTOR, VACUUM, FETAL |
| Product Code | HDB |
| Date Received | 2020-02-07 |
| Model Number | VAC-6000M |
| Catalog Number | VAC-6000M |
| Lot Number | 190403 |
| Device Availability | Y |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS, LLC |
| Manufacturer Address | 747 WEST 4170 SOUTH MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |