MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-21 for INTRAN PLUS IUP-400 5336 manufactured by Utah Medical Products, Inc..
[6479]
The intrauterine pressure catheter was inserted in the pt. Negative numbers registered on the monitor, and the device could not be zeroed. The monitor and monitor cables were changed, but the device could not be zeroed. A different lot number of the same device was tried with the same results. The personnel decided to change the type of catheter to another by same mfr. This device worked well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003467 |
| MDR Report Key | 16304 |
| Date Received | 1994-09-21 |
| Date of Report | 1994-09-09 |
| Date of Event | 1994-08-23 |
| Date Added to Maude | 1994-09-22 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Product Code | KXO |
| Date Received | 1994-09-21 |
| Model Number | IUP-400 |
| Catalog Number | 5336 |
| Lot Number | 41278-1, 41967-1 |
| Device Expiration Date | 1999-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16237 |
| Manufacturer | UTAH MEDICAL PRODUCTS, INC. |
| Manufacturer Address | MIDVALE UT 84047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-09-21 |