VEST RESTRAINT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-25 for VEST RESTRAINT manufactured by Mri-div Of De Royal Industries, Inc..

Event Text Entries

[3446] On december 16 at 4:12 am a resident was found expired on the floor next to his bed. He was in a vest restraint. The side rails of his bed were down, though the rails were in place when he was last observed. The cause of death was not immediately ascertainable so the medical examiner is reviewing the incident. Other device: bed: gem southeast, inc. Invalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. 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. 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: 5749
• MDR Report Key: 5749
• Date Received: 1993-06-25
• Date of Report: 1992-12-24
• Date of Event: 1992-12-16
• Report Date: 1992-12-24
• Date Reported to FDA: 1992-12-24
• Date Added to Maude: 1993-07-22
• 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: VEST RESTRAINT
• Generic Name: RESTRAINT
• Product Code: BRT
• Date Received: 1993-06-25
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5446
• Manufacturer: MRI-DIV OF DE ROYAL INDUSTRIES, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-06-25