MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-18 for LIDO 820294-01 manufactured by Loredam Biomedical, Inc..
[16368]
Pt was doing isokinetic workout. Washer was broken. And machine twisted due to torque, which caused valgus stress on the joint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 30535 |
| MDR Report Key | 30535 |
| Date Received | 1996-01-18 |
| Date of Report | 1995-12-01 |
| Date of Event | 1995-10-09 |
| Date Facility Aware | 1995-10-18 |
| Report Date | 1996-01-09 |
| Date Added to Maude | 1996-03-01 |
| 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 | LIDO |
| Generic Name | LIDO |
| Product Code | IKK |
| Date Received | 1996-01-18 |
| Model Number | 820294-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31598 |
| Manufacturer | LOREDAM BIOMEDICAL, INC. |
| Manufacturer Address | 3650 INDUSTRIAL BLVD WEST SACRAMENTO CA 95691 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-01-18 |