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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WINDSOR DIRECT FOLDEASY3; FOLD EASY PORTABLE TOILET FRAME
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WINDSOR DIRECT FOLDEASY3; FOLD EASY PORTABLE TOILET FRAME Back to Search Results
Device Problem Component Falling (1105)
Patient Problems Emotional Changes (1831); Pain (1994); Discomfort (2330); Injury (2348)
Event Date 11/05/2016
Event Type  Injury  
Event Description
Patient reports that while using the device, the device toppled and patient fell to the floor.Patient was hospitalized and underwent open reduction and internal fixation surgery with intramedullary nail for right hip intertrochanteric femur three-part fracture.Verified complaint, court of (b)(6), (b)(6), filed on (b)(6) 2017: "that by reason of the negligence of the defendants, its agents, servants and/or employees, the plaintiff, (b)(6), sustained severe and serious personal injuries: she has been rendered, sick, sore, lame and disabled and still suffers from great bodily pain and mental anguish; he was and still is unable to perform her usual duties, vocation and education; she has been caused to and continues to need medical care, aid, and attention; some of her injuries are permanent in nature.(b)(6) distribution llc, (b)(6).
 
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Brand Name
WINDSOR DIRECT FOLDEASY3
Type of Device
FOLD EASY PORTABLE TOILET FRAME
MDR Report Key7384699
MDR Text Key104068269
Report NumberMW5076237
Device Sequence Number1
Product Code ILS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 03/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/29/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age78 YR
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