MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2004-02-25 for CRD-201 manufactured by Utah Medical Products, Inc..
[366429]
The cordguard was used during a difficult c-section, insulin dependent diabetic mother, with a large baby. After the umbilical cord was cut and the infant was moved from the field the clamp came off. The infant lost an undetermined amount of blood. Both the mother and the baby are doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718873-2004-00001 |
| MDR Report Key | 513023 |
| Report Source | 04,05,06 |
| Date Received | 2004-02-25 |
| Date of Report | 2004-02-20 |
| Date of Event | 2004-02-06 |
| Date Mfgr Received | 2004-02-06 |
| Date Added to Maude | 2004-02-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BEN SHIRLEY, VP |
| Manufacturer Street | 7043 S 300 W |
| Manufacturer City | MIDVALE UT 84047 |
| Manufacturer Country | US |
| Manufacturer Postal | 84047 |
| Manufacturer Phone | 8015861200 |
| Manufacturer G1 | UTAH MEDICAL PRODUCTS, INC. |
| Manufacturer Street | 7043 S 300 W |
| 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 | CRD-201 |
| Generic Name | CORDGUARD II |
| Product Code | HFW |
| Date Received | 2004-02-25 |
| Returned To Mfg | 2004-02-13 |
| Model Number | NA |
| Catalog Number | CRD-201 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 502030 |
| Manufacturer | UTAH MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE UT 840471048 US |
| Baseline Brand Name | CRD-201 |
| Baseline Generic Name | CORDGUARD II |
| Baseline Model No | NA |
| Baseline Catalog No | CRD-201 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-02-25 |