MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-06 for ENDOLAP * 24593-044A manufactured by Cardinal Health.
[464208]
During an or procedure when patient was under anesthesia, the surgeon was preparing the patient's limb for the tourniquet to be inflated. The esmark in question was applied to the patient's hand and arm to decrease the amount of blood in the limb prior to inflation of the tourniquet. As the physician was wrapping the esmark around the patient, it broke apart, nearly hitting the doctor in the face. This has happened on other occasions according to physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 706738 |
| MDR Report Key | 706738 |
| Date Received | 2006-04-06 |
| Date of Report | 2006-04-06 |
| Date of Event | 2006-03-20 |
| Report Date | 2006-04-06 |
| Date Reported to FDA | 2006-04-06 |
| Date Added to Maude | 2006-05-03 |
| 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 | ENDOLAP |
| Generic Name | BANDAGE, ESMARK |
| Product Code | MHW |
| Date Received | 2006-04-06 |
| Model Number | * |
| Catalog Number | 24593-044A |
| Lot Number | JQ-2005-1595-1 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 695802 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN ROAD MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-06 |