MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-14 for MEDICHOICE * manufactured by Owens & Minor.
[1049522]
Blade on cord clamp remover dislodged while removing clamp,which became stuck on clamp while attached to the baby. The blade was loose, but device could not be removed from the newborn. This posed a danger to the baby and took much effort from three rns to remove it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1366456 |
| MDR Report Key | 1366456 |
| Date Received | 2009-04-14 |
| Date of Report | 2009-04-14 |
| Date of Event | 2009-03-13 |
| Report Date | 2009-04-14 |
| Date Reported to FDA | 2009-04-14 |
| Date Added to Maude | 2009-04-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE |
| Generic Name | CORD CLAMP REMOVER, UMBILICAL |
| Product Code | HFW |
| Date Received | 2009-04-14 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | CCG09-31 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR |
| Manufacturer Address | 14245 MAGELLAN ROAD HANOVER MD 21076 US 21076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-14 |