MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-17 for STARLINER 982042 manufactured by Everest & Jennings Wheelchair.
[2942]
Resident hit (l) arm on cracked, broken plastic arm of wheelchair causing a skin tear. Wheelchair sent to maintenance department to be repaired. Resident's (l) arm skin tear cleansed and a steri-strip was appliedinvalid 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: other. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5021 |
| MDR Report Key | 5021 |
| Date Received | 1993-06-17 |
| Date of Report | 1993-06-02 |
| Date of Event | 1993-05-31 |
| Date Facility Aware | 1993-05-31 |
| Report Date | 1993-06-02 |
| Date Added to Maude | 1993-06-22 |
| 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 | STARLINER |
| Product Code | IML |
| Date Received | 1993-06-17 |
| Model Number | 982042 |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 4724 |
| Manufacturer | EVEREST & JENNINGS WHEELCHAIR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-06-17 |