BED, WITH SIDE RAIL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-05-25 for BED, WITH SIDE RAIL manufactured by Lumex, Inc..

Event Text Entries

[792] Resident was found lying on right side with (r) foot and leg extended through side rail. When reposition (r) leg and foot abducted and rotated. Upper (r) extremity edematous, toes cyanotic. X-ray revealed fx. (r) hipinvalid 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: actual device involved in incident was evaluated, performance tests performed, visual examination. Results of evaluation: none or unknown. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 611
• MDR Report Key: 611
• Date Received: 1992-05-25
• Date of Report: 1992-05-06
• Date of Event: 1992-05-02
• Date Facility Aware: 1992-05-03
• Report Date: 1992-05-06
• Date Reported to FDA: 1992-05-06
• Date Added to Maude: 1992-05-26
• 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

• Generic Name: BED, WITH SIDE RAIL
• Product Code: FNK
• Date Received: 1992-05-25
• Operator: OTHER
• Device Availability: Y
• Device Age: 01-JUN-84
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 601
• Manufacturer: LUMEX, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-05-25