MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-06 for STRYKER MEDICAL SYMMETRY PLUS RECLINER 3502-109-001 manufactured by Stryker Medical.
[22043646]
The pt underwent back surgery for a recurrent herniated disk. On post-operative day one, the pt sat in a reclining chair in his hospital room. When the pt attempted to get up from the chair, he pushed the leg rest back with his feet. When the back did not move up, he used the ottoman release handle on the side of the chair. The chair returned to the upright position with significant force that resulted in the pt having to return to the operating room for an add'l surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024174 |
| MDR Report Key | 2446053 |
| Date Received | 2012-02-06 |
| Date of Report | 2011-08-09 |
| Date of Event | 2011-06-23 |
| Date Added to Maude | 2012-02-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER MEDICAL SYMMETRY PLUS RECLINER |
| Generic Name | RECLINER CHAIR |
| Product Code | FRJ |
| Date Received | 2012-02-06 |
| Model Number | 3502-109-001 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL |
| Manufacturer Address | PORTAGE MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-02-06 |