MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-21 for ROLLS E1188A280 manufactured by Invacare.
[2238]
Two certified nursing assistants were transferring resident to bed when the resident's legs collapsed. Resident's leg hit foot pedal on wheelchair causing an open wound. Resident was sent to emergency room of hospital for stitches. Device not labeled for single use. Patient medical status prior to event: satisfactory 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: actual device involved in incident was evaluated, visual examination. Results of evaluation: other. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3829 |
| MDR Report Key | 3829 |
| Date Received | 1993-01-21 |
| Date of Report | 1992-08-05 |
| Date of Event | 1992-07-20 |
| Date Facility Aware | 1992-07-20 |
| Report Date | 1992-08-05 |
| Date Reported to Mfgr | 1992-08-05 |
| Date Added to Maude | 1993-05-06 |
| 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 | ROLLS |
| Generic Name | WHEELCHAIR WITH FOOT PEDAL |
| Product Code | IMM |
| Date Received | 1993-01-21 |
| Model Number | E1188A280 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3571 |
| Manufacturer | INVACARE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-01-21 |