MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-12-28 for CYBEX WITH HUMAC 6000 * manufactured by Cybex International, Inc..
[19682916]
The physician requested testing on patient's anterior cruciate ligament (acl) repair. The patient was performing the desired test on the cybex machine when the machine failed to stop her motion and created a hyperextension to the limb that was being tested. The patient claimed it felt like the machine "let her go. " the test was halted and attempted again and the same result happened so the test was terminated. This particular problem had been observed before. The patient suffered no harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 802065 |
| MDR Report Key | 802065 |
| Date Received | 2006-12-28 |
| Date of Report | 2006-12-28 |
| Date of Event | 2006-07-26 |
| Report Date | 2006-12-28 |
| Date Reported to FDA | 2006-12-28 |
| Date Added to Maude | 2007-01-10 |
| 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 | CYBEX WITH HUMAC |
| Generic Name | EXTREMITY SYSTEM |
| Product Code | IKK |
| Date Received | 2006-12-28 |
| Model Number | 6000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 10 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 789577 |
| Manufacturer | CYBEX INTERNATIONAL, INC. |
| Manufacturer Address | 10 TROTTER DRIVE MEDWAY MA 02053 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-28 |