MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-06-27 for UMBILI-CATH 4275005 manufactured by Utah Medical Products, Inc..
| Report Number | 1718873-2019-00001 |
| MDR Report Key | 8742138 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-06-27 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-05-10 |
| Date Facility Aware | 2019-05-10 |
| Report Date | 2019-05-23 |
| Date Reported to Mfgr | 2019-05-23 |
| Date Mfgr Received | 2019-06-03 |
| Device Manufacturer Date | 2018-02-21 |
| Date Added to Maude | 2019-06-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Manufacturer Contact | BEN SHIRLEY |
| Manufacturer Street | 7043 SOUTH 300 WEST |
| Manufacturer City | MIDVALE UT 84047 |
| Manufacturer Country | US |
| Manufacturer Postal | 84047 |
| Manufacturer Phone | 8015661200 |
| Manufacturer G1 | UTAH MEDICAL PRODUCTS INC. |
| Manufacturer Street | 7043 SOUTH 300 WEST |
| Manufacturer City | MIDVALE UT 84047 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84047 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UMBILI-CATH |
| Generic Name | UBILICAL CATHETER |
| Product Code | FOS |
| Date Received | 2019-06-27 |
| Model Number | NA |
| Catalog Number | 4275005 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UTAH MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE UT 84047 US 84047 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-06-27 |