MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-03-15 for UNIVERSAL 961032 UNKNOWN manufactured by Everest And Jennings Inc..
[3420]
Patient was found on the floor of his room, in his wheelchair. He was restrained, restraint was stilll intact, wheelchair was on it's side, as was patient. Patient sustained a fractured skull. Patient was transferred to rockville general hospital and died seven days later. Invalid data - regarding single use labeling of device. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5397 |
| MDR Report Key | 5397 |
| Date Received | 1993-03-15 |
| Date of Report | 1993-02-24 |
| Date of Event | 1993-02-02 |
| Date Facility Aware | 1993-02-02 |
| Report Date | 1993-02-24 |
| Date Reported to Mfgr | 1993-02-24 |
| Date Added to Maude | 1993-07-12 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL |
| Generic Name | NA |
| Product Code | KID |
| Date Received | 1993-03-15 |
| Model Number | 961032 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 5093 |
| Manufacturer | EVEREST AND JENNINGS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1993-03-15 |