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..
[112776]
At 1320 g6 p5 in early labor with pitocin augmentation. Koala iupc placed by physician. 1525 pitocin off due to fhr deceleration. 1540 fetal bradycardia x 19 min. Pt to or for cesarian. Placental abruption noted at time of cesarian. Baby born at 1610.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012168 |
| MDR Report Key | 122716 |
| 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 | 3 |
| 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 | 120187 |
| 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 |