24442

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-01 for 24442 manufactured by Technol.

Event Text Entries

[22070761] Patient was found motionless on the asphalt grounds of the hospital courtyard. Patient resuscitated unsuccessfully in er. Patient's bed still with 4 siderails up, upper limb, lower limb restraints attached to be, left lower limb restraint broken, no withnesses to actualfalldevice labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding 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. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3640
• MDR Report Key: 3640
• Date Received: 1993-01-01
• Date of Report: 1992-06-27
• Date of Event: 1992-06-27
• Date Facility Aware: 1992-06-27
• Report Date: 1992-06-27
• Date Added to Maude: 1993-04-28
• 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: WRIST RESTRAINT
• Product Code: KID
• Date Received: 1993-01-01
• Catalog Number: 24442
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3386
• Manufacturer: TECHNOL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-01-01