SKIL-CARE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-31 for SKIL-CARE * manufactured by Skil-care Corp.

Event Text Entries

[309000] Pt found in wc with their safety belt around neck. Resident was alert with periods of confusion prior to event. Resident removed from w. C. No pulse or resp detected. Paramedics called. Resident pronounced at the scene. Police, m. E. ) 2 state agencies notified.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 512401
• MDR Report Key: 512401
• Date Received: 2004-01-31
• Date of Report: 2004-01-27
• Date of Event: 2004-01-14
• Date Facility Aware: 2004-01-14
• Report Date: 2004-01-27
• Date Reported to FDA: 2004-01-27
• Date Added to Maude: 2004-02-24
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• 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: SKIL-CARE
• Generic Name: SAFETY BELT
• Product Code: IQB
• Date Received: 2004-01-31
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 501411
• Manufacturer: SKIL-CARE CORP
• Manufacturer Address: 29 WELLS AVE YONKERS NY 10701 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2004-01-31