MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-10-18 for MEDICHOICE UMBILICAL CORD CLAMP 88101 manufactured by Deroyal Industries Inc..
[17480772]
Following patient delivery, the umbilical cord was clamped and cut as usual. When applying the cord clamp, it was stated that they attached a transponder to the pt using the cord clamp. At change of shift assessment, a nurse noted blood oozing from the cord; therefore, a new cord clamp was attached and the bleeding stopped. No complications or injuries to the pt were reported. When the original clamp was inspected, the user facility reported that it appeared to be "slightly bowed. " the user facility also indicated that the nurses were not certain if the transponder was properly aligned in the clamp. The nurses reported that they "have not had a similar experience in the year-plus facility has been using this clamp. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1046367-2005-00002 |
| MDR Report Key | 642380 |
| Report Source | 06 |
| Date Received | 2005-10-18 |
| Date of Report | 2005-10-07 |
| Date of Event | 2005-08-26 |
| Date Mfgr Received | 2005-09-06 |
| Date Added to Maude | 2005-10-25 |
| 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 | 0 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | DEROYAL SURGICAL ROSE HILL |
| Manufacturer Street | 100 ROSE HILL INDUSTRIAL PARK |
| Manufacturer City | ROSE HILL VA 24281 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 24281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE UMBILICAL CORD CLAMP |
| Generic Name | UMBILICAL CORD CLAMP |
| Product Code | FOD |
| Date Received | 2005-10-18 |
| Model Number | NA |
| Catalog Number | 88101 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 631909 |
| Manufacturer | DEROYAL INDUSTRIES INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | MEDICHOICE UMBILICAL CORD CLAMP |
| Baseline Generic Name | UMBILICAL CORD CLAMP |
| Baseline Model No | NA |
| Baseline Catalog No | 88101 |
| Baseline ID | NONE |
| Baseline Device Family | BIRTHING AND NEONATAL PRODUCTS |
| 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 | 2005-10-18 |