MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-18 for INTRAN PLUS IUP-400 * manufactured by Utah Medical Products, Inc..
[981583]
Iupc sensor has small plastic wrap around it that could possibly be left in patient if not seen during placement. Not used on a patient - no harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282083 |
| MDR Report Key | 1282083 |
| Date Received | 2008-12-18 |
| Date of Report | 2008-12-18 |
| Date of Event | 2008-12-02 |
| Report Date | 2008-12-18 |
| Date Reported to FDA | 2008-12-18 |
| Date Added to Maude | 2009-01-09 |
| 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 |
| 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 | CATHETER SYSTEM, INTRAUTERINE PRESSURE |
| Product Code | KXO |
| Date Received | 2008-12-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 1081451 |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UTAH MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 7043 SOUTH 300TH STREET WEST MIDVALE UT 84047 US 84047 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-18 |