MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-04-03 for KIWI COMPLETE VACUUM DELIVERY SYSTEM VAC-6000MTE manufactured by Clinical Innovations, Llc.
[140819627]
Clinical innovations is investigating the incident. User facility did report that both mother and baby are doing fine. If any additional information is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[140819628]
2 x kiwis deflated no caput. It is not clear if hematoma was from kiwicup or forceps. It was not a visible tear. Mother went to hdu unit, due to hematoma, both are fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2019-00002 |
| MDR Report Key | 8479632 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-04-09 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-04-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ANDREA GADSBY |
| Manufacturer Street | 747 W 4170 S |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012688200 |
| Manufacturer G1 | CLINICAL INNOVATIONS, LLC |
| 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 COMPLETE VACUUM DELIVERY SYSTEM |
| Generic Name | VACUUM DELIVERY SYSTEM |
| Product Code | HDB |
| Date Received | 2019-04-03 |
| Returned To Mfg | 2019-04-01 |
| Model Number | VAC-6000MTE |
| Lot Number | 180824 |
| 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, LLC |
| Manufacturer Address | 747 W 4170 S MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-03 |