MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-07-08 for INTRAN PLUS IUP-400 50525 manufactured by Utah Medical Products.
[422909]
Uterine resting tone fluctuated depending upon how the patient was positioned and whether or not the patient was pushing. Abdomen would palpate soft but resting tome was recording as 30-35 mmhg. Patient delivered viable pt without incident. Many devices from this manufacturer have been reading high for a period of time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 621817 |
| MDR Report Key | 621817 |
| Date Received | 2005-07-08 |
| Date of Report | 2005-07-08 |
| Date of Event | 2005-06-27 |
| Report Date | 2005-07-08 |
| Date Reported to FDA | 2005-07-08 |
| Date Added to Maude | 2005-07-21 |
| 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 |
| Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Product Code | HGS |
| Date Received | 2005-07-08 |
| Model Number | IUP-400 |
| Catalog Number | 50525 |
| Lot Number | 150552 |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 611465 |
| Manufacturer | UTAH MEDICAL PRODUCTS |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE UT 84047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-08 |