MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-11 for INTRAN PLUS IUP-400 * manufactured by Utah Medical.
[343738]
Product failed to produce waveform.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033764 |
| MDR Report Key | 558934 |
| Date Received | 2004-11-15 |
| Date of Report | 2004-11-11 |
| Date of Event | 2004-11-03 |
| Date Added to Maude | 2004-12-14 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRAN PLUS |
| Generic Name | DISPOSABLE INTRAUTERINE PRESSURE CATHETER SYSTEM |
| Product Code | KXO |
| Date Received | 2004-11-11 |
| Model Number | IUP-400 |
| Catalog Number | * |
| Lot Number | 140815 |
| ID Number | * |
| Device Expiration Date | 2006-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 548630 |
| Manufacturer | UTAH MEDICAL |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE UT 84047 US |
| Baseline Brand Name | INTRAN PLUS |
| Baseline Generic Name | IUPC |
| Baseline Model No | IUP-400 |
| Baseline Catalog No | IUP-400 |
| Baseline ID | NA |
| Baseline Device Family | INTRAN |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K955443 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-11-15 |