BEDRAIL N0163 10-163

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-21 for BEDRAIL N0163 10-163 manufactured by N&m Industries.

Event Text Entries

[20518420] Resident was found to have bruised and swollen ankle. X-ray showed fracture of ankle. After questioning staff, cause was undetermined, but the general concensus is that residents legs were caught in the bedrail. Bedrail checked and lubricated by maintenance dept. And protective rail covers were placed on railsdevice not labeled for single use. 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: user facility biomedical/bioengineering department. 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: actual device involved in incident was evaluated, performance tests performed, visual examination. Results of evaluation: loss of lubrication. Conclusion: user error caused event. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device returned to manufacturer/dealer/distributor, user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2819
• MDR Report Key: 2819
• Date Received: 1992-07-21
• Date of Report: 1992-01-16
• Date of Event: 1992-01-08
• Date Facility Aware: 1992-01-08
• Report Date: 1992-01-16
• Date Reported to Mfgr: 1992-01-16
• Date Added to Maude: 1993-03-30
• 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

Device Details

• Brand Name: BEDRAIL
• Generic Name: N/A
• Product Code: FNK
• Date Received: 1992-07-21
• Model Number: N0163
• Catalog Number: 10-163
• Lot Number: 10-163
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-APR-88
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2645
• Manufacturer: N&M INDUSTRIES

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-21