MAUDE Adverse Event Report: DURALIFE DURALIFE; SHOWER KOMMODO CHAIR

Device Problems Detachment Of Device Component (1104); Crack (1135)

Patient Problem Fall (1848)

Event Date 06/19/2015

Event Type  malfunction  

Event Description

Edge of seat came up, thus the seat slide forward off the chair along with the resident.Upon inspection the back part of the seat had a crack, where it clips.

• Brand Name: DURALIFE
• Type of Device: SHOWER KOMMODO CHAIR
• Manufacturer (Section D): DURALIFE; south williamsport PA 17702
• MDR Report Key: 5049238
• MDR Text Key: 24926659
• Report Number: MW5055875
• Device Sequence Number: 1
• Product Code: ILS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR