SKIL-CARE * 701030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-25 for SKIL-CARE * 701030 manufactured by Skil-care.

Event Text Entries

[107298] Pt had been observed sleeping in his wheelchair in resident room with self release belt on at approximately 9:20 a. M. By a registered nursing assistant. At approximately 9:25 a. M. A different registered nursing assistant found pt sitting on floor with self-release belt around neck. Pt was blue in color. The registered nursing assistant got assistance from an lpn and they released pt from belt. Pt's color returned and vitals were within normal range. The charge nurse entered room and assessed pt's vitals continued within normal range but pt was not responsive. Pt's doctor was called and came to facility to assess resident. Doctor examined and initial exam indicated possible neurological event. Family was here and conferred with doctor. Family and pt had previous discussion regarding pt's wishes and pt was kept comfortable. Pt died on tuesday, february 17,1998 of hypoxic encephalopathy as determined by the county coroner on monday, february 23,1998. Coroner ruled it an accidental death. Pt had history of numerous falls that were initiated with pt opening self-release belt and sliding to floor. There had been no prior incidents where belt did not release and by all indications pt had not tried to release belt. The belt had been properly installed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 153126
• MDR Report Key: 153126
• Date Received: 1998-02-25
• Date of Report: 1998-02-24
• Date of Event: 1998-02-14
• Date Facility Aware: 1998-02-14
• Report Date: 1998-02-23
• Date Reported to FDA: 1998-02-24
• Date Reported to Mfgr: 1998-02-24
• Date Added to Maude: 1998-03-03
• 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: 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: SELF-RELEASE BELT-VELCRO
• Product Code: IQB
• Date Received: 1998-02-25
• Model Number: *
• Catalog Number: 701030
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 149187
• Manufacturer: SKIL-CARE
• Manufacturer Address: 29 WELLS AVE YONKERS NY 10701 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1998-02-25