MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-05-17 for UNKNOWN manufactured by Unknown.
[2646]
Resident was found with head stuck in right side rail on bed, had scrapped area 1/2" on forehead with read area on neck. Resident developed 4 and 1/2" bruise on forhead around scraped area. Side rails were covered with foam padding with sheet wrapped around them to prevent further injurydevice 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: unknown. Service records not available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: mechanical tests performed, performance tests performed. Results of evaluation: telemetry failure, none or unknown. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5177 |
| MDR Report Key | 5177 |
| Date Received | 1993-05-17 |
| Date of Report | 1993-05-04 |
| Date of Event | 1993-03-29 |
| Date Facility Aware | 1993-03-29 |
| Report Date | 1993-05-04 |
| Date Added to Maude | 1993-06-29 |
| 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 | UNKNOWN |
| Generic Name | UNKNOWN |
| Product Code | FNK |
| Date Received | 1993-05-17 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 4878 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-05-17 |