MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-02 for KOALA IUPC INTRAUTERINE PRESSURE CATHETER IPC-5000E manufactured by Clinical Innovations, Llc.
[173724479]
The koala catheter is specifically designed to be as atraumatic as possible, thus such an incident is extremely rare over its 20+ year history. An internal investigation of the incident concluded that the most likely root cause is the inadvertent advancement of the introducer beyond the opening of the cervix, as this is the only material that is stiff enough to potentially cause trauma to the fetus. The distributor will provide training to the hospital to stress the point that the introducer should not advance the providers fingers placed at the cervical opening. If any additional information is received, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[173724480]
A baby had a "bruised" scar in the face after delivery and the parents sharply complained about it to the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2020-00001 |
| MDR Report Key | 9541191 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-02 |
| Date Mfgr Received | 2019-12-11 |
| Date Added to Maude | 2020-01-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KELLIE STEFANIAK |
| 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 | KOALA IUPC INTRAUTERINE PRESSURE CATHETER |
| Generic Name | TRANSDUCER, PRESSURE, INTRAUTERINE |
| Product Code | HFN |
| Date Received | 2020-01-02 |
| Model Number | IPC-5000E |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-02 |