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 2019-05-22 for DEVICE: KIWI OMNICUP VAC-6000MTE manufactured by Clinical Innovations.
[145846824]
This is being reported since information suggests that during use with this device, it did not maintain vacuum. It is unknown whether the c-section was the result of another factor. Information reported indicated the patient was traumatized, but no further detail provided. Sample analysis:no sample has been returned conclusion; unable to confirm the complaint since no sample was returned. Device history lot review: there is nothing relative to this lot. If any additional information becomes available, a supplemental will be reported. This complaint is now closed.
Patient Sequence No: 1, Text Type: N, H10
[145846825]
Kiwi applied correctly then deflated at first attempt to pull. Not a pop-off. There was caput this time so vacuum had to be achieved. It was reported the patient was traumatized but no further detail provided. The patient underwent a c-section under general anesthesia. No sample available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2019-00010 |
| MDR Report Key | 8633595 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-03-25 |
| Date Added to Maude | 2019-05-22 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | DEVICE: KIWI OMNICUP |
| Generic Name | KIWI VACUUM DELIVERY SYSTEM, OMNICUP? WITH TRACTION FORCE INDICATOR |
| Product Code | HDB |
| Date Received | 2019-05-22 |
| Model Number | VAC-6000MTE |
| Lot Number | 180824 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-05-22 |