MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-01 for INTRAN PLUS IUP-400 * manufactured by Utah Medical Prod Inc.
[215642]
Pt undergoing induction of labor. Intrauterine pressure catheter inserted by m. D. Uterine contractions not tracing appropriately. Iupc removed by nurse. Pratratine covering was broken exposing wires.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 318834 |
| MDR Report Key | 318834 |
| Date Received | 2001-03-01 |
| Date of Report | 2001-03-01 |
| Date of Event | 2001-02-28 |
| Date Facility Aware | 2001-02-28 |
| Report Date | 2001-03-01 |
| Date Reported to FDA | 2001-03-01 |
| Date Reported to Mfgr | 2001-03-01 |
| Date Added to Maude | 2001-03-07 |
| 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 | INTRAN PLUS IUP-400 |
| Generic Name | DISPOSABLE INTRAUTERINE PRESSURE CATHETER |
| Product Code | HGS |
| Date Received | 2001-03-01 |
| Model Number | IUP-400 |
| Catalog Number | * |
| Lot Number | 191867-1 |
| ID Number | * |
| Device Expiration Date | 2004-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 308379 |
| Manufacturer | UTAH MEDICAL PROD INC |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE UT 84047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-03-01 |