MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-06-11 for DEROYAL UMBILICAL CORD CLAMP 6833-B manufactured by Deroyal Industries, Inc.
[17513083]
Swaddled baby was found with blood on his blankets. When the blankets were removed, the umbilical cord clamp was found unlatched off of the umbilical cord. The baby lost approx 75-80cc of blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1055236-1999-00004 |
| MDR Report Key | 227151 |
| Report Source | 06 |
| Date Received | 1999-06-11 |
| Date of Report | 1999-06-10 |
| Date of Event | 1999-05-12 |
| Date Facility Aware | 1999-05-12 |
| Report Date | 1999-06-10 |
| Date Mfgr Received | 1999-05-12 |
| Device Manufacturer Date | 1997-12-01 |
| Date Added to Maude | 1999-06-16 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL UMBILICAL CORD CLAMP |
| Generic Name | UMBILICAL CORD CLAMP |
| Product Code | FOD |
| Date Received | 1999-06-11 |
| Model Number | NA |
| Catalog Number | 6833-B |
| Lot Number | 31038 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 220256 |
| Manufacturer | DEROYAL INDUSTRIES, INC |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | UMBILICAL CORD CLAMP |
| Baseline Generic Name | UMBILICAL CORD CLAMP |
| Baseline Model No | NA |
| Baseline Catalog No | 6833-B |
| Baseline ID | NA |
| Baseline Device Family | UMBILICAL OCCLUSION DEVICE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1999-06-11 |