MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-26 for PATHFINDER PLUS PA701 manufactured by Utah Medical Products.
[1423009]
No pt injury or involvement. The pathfinder plus was very slow to fill, meaning it cannot be used for intended purpose. There were two from the same lot sequentially rejected and replaced by same item with different lot number which worked fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014943 |
| MDR Report Key | 1621604 |
| Date Received | 2010-02-26 |
| Date of Report | 2010-02-26 |
| Date Added to Maude | 2010-03-12 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATHFINDER PLUS |
| Generic Name | CONTINUOUS AND PULSATILE IRRIGATION BULB |
| Product Code | GBQ |
| Date Received | 2010-02-26 |
| Model Number | PA701 |
| Lot Number | 1092406 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UTAH MEDICAL PRODUCTS |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE UT 84047104 US 84047 1048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-02-26 |