MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-27 for CLAMP CLAMP-001 * manufactured by Mcroberts Security Technologies.
[2091318]
Cord clamps used to secure infant locator sensors cut through one of the umbilical vessels. There is a right angle on the clamp; if the cord is thick, it might get caught and cause exsanguination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2151705 |
| MDR Report Key | 2151705 |
| Date Received | 2011-06-27 |
| Date of Report | 2011-06-27 |
| Date of Event | 2011-06-14 |
| Report Date | 2011-06-27 |
| Date Reported to FDA | 2011-06-27 |
| Date Added to Maude | 2011-07-06 |
| 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 |
| 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 | CLAMP |
| Generic Name | UMBILICAL CLAMP |
| Product Code | HFW |
| Date Received | 2011-06-27 |
| Model Number | CLAMP-001 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MCROBERTS SECURITY TECHNOLOGIES |
| Manufacturer Address | 1985 SWARTHMORE AVENUE SUITE 7 LAKEWOOD NJ 08701 US 08701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-27 |