MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-24 for KOALA * IPC 5000 manufactured by Clinical Innovations, Inc.
[112777]
Pt in early labor with srom. Koala iupc inserted by midwife at 1334 on 9/14/97. Cervix was 5 cm/90% effacement, station 1. Pt had 2 late deceleratons prior to insertion of iupc. Late decels continued after insertion of iupc. Blood return noted when iupc placed. Placental abruption noted at time of cesarian. Baby born at 1502.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012169 |
| MDR Report Key | 122722 |
| Date Received | 1997-09-24 |
| Date of Report | 1997-09-24 |
| Date of Event | 1997-09-14 |
| Date Added to Maude | 1997-09-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOALA |
| Generic Name | IUPC INTRAUTERINE PRESSURE CATHETER |
| Product Code | KXO |
| Date Received | 1997-09-24 |
| Model Number | * |
| Catalog Number | IPC 5000 |
| Lot Number | 970104 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 120193 |
| Manufacturer | CLINICAL INNOVATIONS, INC |
| Manufacturer Address | 6477 S COTTONWOOD ST MURRAY UT 84107 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1997-09-24 |