SKILCARE SAFETY VEST UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-01 for SKILCARE SAFETY VEST UNKNOWN manufactured by Skilcare Corporation.

Event Text Entries

[333] Patient found lying in bed with vest restraint straps around her neck. Nurse untied the left restraint strap and the neck area was red with strp imprint. She had a faint radial pulse. Cpr was initiated and 911 was called. Squad arrived and transported pt to hospital. Pt. Dx: huntington's disease. She had physicians orders for vest restraint at all times. Her bed was padded all the way around to prevent resident from injury to herselfdevice 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: a device from same lot was evaluated, visual examination. Results of evaluation: telemetry failure. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations, user education provided, inserviced by other facility staff. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1086
• MDR Report Key: 1086
• Date Received: 1992-07-01
• Date of Report: 1992-06-24
• Date of Event: 1992-06-14
• Date Facility Aware: 1992-06-14
• Report Date: 1992-06-24
• Date Reported to FDA: 1992-06-24
• Date Added to Maude: 1992-08-20
• 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: SKILCARE SAFETY VEST
• Generic Name: N/A
• Product Code: BRT
• Date Received: 1992-07-01
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UBK
• Operator: OTHER CAREGIVERS
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1040
• Manufacturer: SKILCARE CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-07-01