MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-02-07 for KOALA IPC-5000C * manufactured by Clinical Innovations, Inc..
[287459]
Co's sales rep, reported the following: in 2003 at 12:55 pm, dr. Detemined that it was necessary to utilize a koala ipc 5000c. Upon insertion, clinicians noticed a large amount of blood draining from the catheter and noted an increase in vaginal bleeding. Rapid onset of fetal bradycardia necessitated the delivery of the infant via emergency ceasarean delivery. Apgar scores were 0 at 1 minute, 0 at 5 minutes. 20 minutes of resuscitative efforts and an emergency transfusion were required to stabilize the pt. Upon delivery of the placenta, a perforation at the junction of the umbilical cord and the placenta was observed. The physician's impression is that the iupc punctured the umbilical cord. The baby was stabilized and sent to hosp. Baby was discharged 1 week later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2003-00001 |
| MDR Report Key | 441709 |
| Report Source | 05 |
| Date Received | 2003-02-07 |
| Date of Report | 2003-02-06 |
| Date of Event | 2003-01-16 |
| Date Mfgr Received | 2003-02-03 |
| Date Added to Maude | 2003-02-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WM. DEAN WALLANCE |
| Manufacturer Street | 474 WEST 4170 SOUTH |
| Manufacturer City | MURRY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012688200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOALA |
| Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Product Code | HGS |
| Date Received | 2003-02-07 |
| Model Number | IPC-5000C |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 430684 |
| Manufacturer | CLINICAL INNOVATIONS, INC. |
| Manufacturer Address | 747 WEST 4170 SOUTH MURRAY UT 84123 US |
| Baseline Brand Name | KOALA |
| Baseline Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Baseline Model No | IPC-5000C |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2003-02-07 |