MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-16 for SYMMETRY PLUS 3500-000-710 manufactured by Stryker Medical.
[3270588]
Patient in recliner to be examined. Nurse practitioner pulled the footrest handle to elevate the feet and it snapped sharply upward. Patient complained she heard a loud pop in her left knee and a few minutes later it started to cause pain and swelling. Examination showed some swelling. X-ray showed moderate effusion and next day patient was in pain. Patient had mri which showed large hemorrhagic joint effusion of left knee with no major structural anomolies identified. Possible strain of bicep femoris muscle. Nursing in two different sites report workarounds with this chair as it does have a strong spring and can cause hyper-extension to patient's knees. They will hold the foot rest down with their hands or tell patient to hold feet up until the footrest is in place. What was the original intended procedure? To have pt recline for examination. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3076690 |
| MDR Report Key | 3076690 |
| Date Received | 2013-04-16 |
| Date of Report | 2013-04-16 |
| Date of Event | 2013-04-10 |
| Report Date | 2013-04-16 |
| Date Reported to FDA | 2013-04-16 |
| Date Reported to Mfgr | 2013-04-25 |
| Date Added to Maude | 2013-04-25 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | SYMMETRY PLUS |
| Generic Name | CHAIR, MEDICAL, EXAMINATION |
| Product Code | FRJ |
| Date Received | 2013-04-16 |
| Model Number | 3500-000-710 |
| Catalog Number | 3500-000-710 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002582 US 49002 5826 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-16 |