MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-19 for CVX-RIPE CVX-100 manufactured by Utah Medical Products, Inc..
| Report Number | 8711829 |
| MDR Report Key | 8711829 |
| Date Received | 2019-06-19 |
| Date of Report | 2019-06-05 |
| Date of Event | 2019-05-19 |
| Report Date | 2019-06-05 |
| Date Reported to FDA | 2019-06-05 |
| Date Reported to Mfgr | 2019-06-19 |
| Date Added to Maude | 2019-06-19 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CVX-RIPE |
| Generic Name | CATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR |
| Product Code | PFJ |
| Date Received | 2019-06-19 |
| Model Number | CVX-100 |
| Catalog Number | CVX-100 |
| Lot Number | 1190088 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-06-19 |