SKIL-CARE 3001 SAME

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-10-22 for SKIL-CARE 3001 SAME manufactured by Skil-care.

Event Text Entries

[1182] Nursing home resident was restrained in invacare wheelchair with a skil-care shoulder strap poncho restraint. She was found having slid out of the front of the chair with her head resting near the front of the seat. The restraint was bunched up near her neck and upper torso. The restraint was immediately removed because it had only been 10-15 minutes since she was last checked on. The cause of death was not known to us until the coroner's report was received on 10/6/92. The coroner ruled that the cause of death was hanging, acidentialdevice not labeled for single use. 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, other. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1720
• MDR Report Key: 1720
• Date Received: 1992-10-22
• Date of Report: 1992-10-09
• Date of Event: 1992-08-23
• Date Facility Aware: 1992-10-06
• Report Date: 1992-10-09
• Date Reported to FDA: 1992-10-09
• Date Reported to Mfgr: 1992-10-09
• Date Added to Maude: 1992-11-18
• 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: SKIL-CARE
• Generic Name: PONCHO RESTRAINT
• Product Code: KID
• Date Received: 1992-10-22
• Model Number: 3001
• Catalog Number: SAME
• Lot Number: UNKNOWN
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1626
• Manufacturer: SKIL-CARE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-10-22