MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-05-31 for 6833 UMBILICAL CORD CLAMP, 100/CS 07 manufactured by Deroyal.
[179480]
Baby losing blood through the cord clamp. This occurred after cord clipping procedure. Baby required no additional treatment. Blood loss at a minimum.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1046367-2000-00020 |
| MDR Report Key | 280311 |
| Report Source | 07 |
| Date Received | 2000-05-31 |
| Date of Report | 2000-05-31 |
| Date of Event | 2000-05-02 |
| Date Facility Aware | 2000-05-02 |
| Report Date | 2000-05-31 |
| Date Reported to FDA | 2000-05-31 |
| Date Mfgr Received | 2000-05-02 |
| Device Manufacturer Date | 1999-12-01 |
| Date Added to Maude | 2000-06-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LN. |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6833 UMBILICAL CORD CLAMP, 100/CS |
| Generic Name | 7N8 UMBILICAL CORD CLAMP |
| Product Code | HFW |
| Date Received | 2000-05-31 |
| Model Number | 07 |
| Catalog Number | 6833 |
| Lot Number | 194854 |
| ID Number | * |
| Device Expiration Date | 2004-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 271270 |
| Manufacturer | DEROYAL |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | UMBILICAL CORD CLAMP, 100/CS |
| Baseline Generic Name | 7N8 UMBILICAL CORD CLAMP |
| Baseline Model No | 07 |
| Baseline Catalog No | 6833 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2000-05-31 |