MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-01-12 for UMBILICAL CORD CLAMP * 6833 manufactured by Deroyal, Inc..
[233987]
Umbilical cord clamp came undone after being applied to cord. Occurred within one hour of birth. Bleeding occurred until new clamp was applied.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1046367-2001-00001 |
| MDR Report Key | 312770 |
| Report Source | 05 |
| Date Received | 2001-01-12 |
| Date of Report | 2001-01-12 |
| Date of Event | 2000-08-01 |
| Date Facility Aware | 2000-12-13 |
| Report Date | 2001-01-12 |
| Date Reported to FDA | 2001-01-12 |
| Date Mfgr Received | 2000-12-13 |
| Date Added to Maude | 2001-01-22 |
| 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 LANE |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UMBILICAL CORD CLAMP |
| Generic Name | UMBILICAL CORD CLAMP |
| Product Code | HFW |
| Date Received | 2001-01-12 |
| Model Number | * |
| Catalog Number | 6833 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 302529 |
| Manufacturer | DEROYAL, INC. |
| Manufacturer Address | 200 DEBUSK LN POWELL TN 37849 US |
| Baseline Brand Name | DEROYAL |
| Baseline Generic Name | UMBILICAL CORD CLAMP |
| Baseline Model No | NA |
| Baseline Catalog No | 6833 |
| Baseline ID | UMBILICAL CORD |
| Baseline Device Family | UMBILICAL CORD CLAMPS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-01-12 |