MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-10-27 for DEROYAL 6833-B manufactured by Deroyal Industries, Inc..
[136895]
After application of umbilical cord clamp, the latch popped open while the infant was still in observation in labor and delivery. Minimal blood loss occurred. A new cord clamp was applied, and no additional treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1055236-1999-00011 |
| MDR Report Key | 247844 |
| Report Source | 06 |
| Date Received | 1999-10-27 |
| Date Reported to FDA | 1999-10-28 |
| Date Mfgr Received | 1999-09-30 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 1999-11-04 |
| 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 | 4239387828 |
| 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 | DEROYAL |
| Generic Name | UMBILICAL CORD CLAMP |
| Product Code | FOD |
| Date Received | 1999-10-27 |
| Model Number | NA |
| Catalog Number | 6833-B |
| Lot Number | 57062 |
| ID Number | NA |
| Device Expiration Date | 2004-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 240111 |
| 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. Other | 1999-10-27 |