MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-17 for VACOPED * manufactured by Oped Inc..
[1390979]
Patient's foot placed in boot and secured. Torque applied and hip distraction acheived. However, an ankle fracture was sustained.
Patient Sequence No: 1, Text Type: D, B5
[1455390]
Patient's foot placed in boot and secured. Torque applied and hip distraction acheived. However, an ankle fracture was sustained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1545303 |
| MDR Report Key | 1545303 |
| Date Received | 2009-11-17 |
| Date of Report | 2009-11-13 |
| Date of Event | 2009-10-16 |
| Report Date | 2009-11-13 |
| Date Reported to FDA | 2009-11-17 |
| Date Added to Maude | 2009-11-25 |
| 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 | VACOPED |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2009-11-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OPED INC. |
| Manufacturer Address | 47 LORING DRIVE FRAMINGHAM MA 01702 US 01702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2009-11-17 |