MAUDE Adverse Event Report: AMPLE SOURCE TRADING COMPANY CANE/SLING SEAT

Model Number SST6856

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 12/14/2014

Event Type  malfunction  

Event Description

A customer was in her elevator sitting on her cane sling seat and the seam broke on one of the sides of the seat, causing her to fall to the ground.Dates of use: (b)(6) 2014.Diagnosis or reason for use: used as a mobility aid and chair for rest.

• Brand Name: CANE/SLING SEAT
• Type of Device: CANE/SLING SEAT
• Manufacturer (Section D): AMPLE SOURCE TRADING COMPANY
• MDR Report Key: 4379892
• MDR Text Key: 5266712
• Report Number: MW5039885
• Device Sequence Number: 1
• Product Code: KHY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SST6856
• Other Device ID Number: 017874010882
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1