VEST RESTRAINT 3000 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-11 for VEST RESTRAINT 3000 UNKNOWN manufactured by Skill-care Corp..

Event Text Entries

[3101] The decedent was a long term patient at fair acres who reportedly slipped out of her restraints and was found in a hanging position with the restraint forming a ligature around the neck. The decedent is reported to have a history of huntington's chorea with dementia. Similar devices were being used at this timedevice 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, a device from same lot was evaluated. Results of evaluation: other. Conclusion: no failure detected and product within specification, there was no device failure. Certainty of device as cause of or contributor to event: yes. Corrective actions: user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5001
• MDR Report Key: 5001
• Date Received: 1993-06-11
• Date of Report: 1993-04-05
• Date of Event: 1992-10-14
• Date Facility Aware: 1992-10-14
• Report Date: 1993-04-05
• Date Added to Maude: 1993-06-22
• 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
• Product Code: KID
• Date Received: 1993-06-11
• Model Number: 3000
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4704
• Manufacturer: SKILL-CARE CORP.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-06-11