MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-08-16 for KOALA IPC-5000E * manufactured by Clinical Innovations, Inc..
[292252]
Company's sales representative, reported the following: in 2003 dr. (resident) used a koala iupc 5000e. Dr. Reported that upon insertion there was a blood-tinged flashback of fluid; however, the tracings were fine so she advanced the catheter to the 45 cm mark. Approximately 5 minutes later dr. Noticed a progressive deceleration and a trickle of blood from the vagina. The deceleration did not respond to the usual treatment and an emergent c-section was called. Apgar scores were 0 at 1 minute and 0 at 5 minutes. The pt received a blood transfusion and experienced seizures in the nicu. The pt was discharged after 14 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2003-00002 |
| MDR Report Key | 479439 |
| Report Source | 06 |
| Date Received | 2003-08-16 |
| Date of Report | 2003-08-15 |
| Date of Event | 2003-07-12 |
| Date Mfgr Received | 2003-07-18 |
| Date Added to Maude | 2003-08-26 |
| 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 WALLACE |
| Manufacturer Street | 747 W. 4170 S. |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012688200 |
| Manufacturer G1 | CLINICAL INNOVATINS, INC. |
| 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 |
| Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Product Code | HGS |
| Date Received | 2003-08-16 |
| Model Number | IPC-5000E |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 468280 |
| 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-5000E |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2003-08-16 |