MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-20 for KOALA IPC-5000 * manufactured by Clinical Innovations, Inc..
[76340]
Planned vbac post two c-sections. Pt given cytotec to ripen uterus. Intrauterine pressure monitored with device. Uterus ruptured requiring emergency c-section and hysterectomy. Amplitude of pressure tracing does not suggest pressures were high enough to cause rupture. Question dampened output of intrauterine pressure monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 127761 |
| MDR Report Key | 127761 |
| Date Received | 1997-10-20 |
| Date of Report | 1997-10-02 |
| Date of Event | 1997-09-27 |
| Date Facility Aware | 1997-09-27 |
| Report Date | 1997-10-02 |
| Date Reported to FDA | 1997-10-02 |
| Date Reported to Mfgr | 1997-10-02 |
| Date Added to Maude | 1997-10-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 | INTRAUTERINE PRESSURE SYSTEM |
| Product Code | HGS |
| Date Received | 1997-10-20 |
| Model Number | IPC-5000 |
| Catalog Number | * |
| Lot Number | 970123 |
| ID Number | BAR CODE H833IPC500014 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 124995 |
| Manufacturer | CLINICAL INNOVATIONS, INC. |
| Manufacturer Address | 6477 SOUTH COTTONWOOD STREET MURRAY UT 84107 US |
| Baseline Brand Name | KOALA INTRAUTERINE PRESSURE CATHETER |
| Baseline Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Baseline Model No | IPC-5000 |
| Baseline Catalog No | IPC-5000 |
| Baseline ID | NA |
| Baseline Device Family | KOALA INTRAUTERINE PRESSURE CATHETERS |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K954955 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1997-10-20 |