HI-LO NONE UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-17 for HI-LO NONE UNKNOWN manufactured by Smith & Davis.

Event Text Entries

[1396] Resident was found in floor at foot of bed, blood dripping down both legs. No blood was seen on bed frame or linens. Siderails were up at the time of injury. Resident apparently worked her legs between footboard and siderails, cutting legs on metal frame on footboard and metal side release. Button. Right & left legs both v shaped skin tear. Resident is 95 years old. Skin is very fragile. Resident poor historian. Total of 38 sutures. Medical device related - report to fainvalid data - regarding single use labeling of device. 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, visual examination, other. Results of evaluation: material degradation/deterioration, none or unknown, patient's condition - predisposed event, unanticipated. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1836
• MDR Report Key: 1836
• Date Received: 1992-11-17
• Date of Report: 1992-11-03
• Date of Event: 1992-11-01
• Date Facility Aware: 1992-11-02
• Report Date: 1992-11-03
• Date Reported to FDA: 1992-11-03
• Date Added to Maude: 1992-12-07
• 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: HI-LO
• Generic Name: UNKNOWN
• Product Code: FNK
• Date Received: 1992-11-17
• Model Number: NONE
• Catalog Number: UNKNOWN
• ID Number: NONE
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 1712
• Manufacturer: SMITH & DAVIS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-11-17