MAUDE Adverse Event Report: NOVA BATH AND SHOWER CHAIR

Model Number 9121

Device Problems Bent (1059); Collapse (1099)

Patient Problem Fall (1848)

Event Date 12/15/2014

Event Type  Injury  

Event Description

Shower chair legs bent and plastic seat started to collapse when i was sitting on the chair for my shower.

• Brand Name: BATH AND SHOWER CHAIR
• Type of Device: BATH AND SHOWER CHAIR
• Manufacturer (Section D): NOVA
• MDR Report Key: 4360712
• MDR Text Key: 5237159
• Report Number: MW5039738
• Device Sequence Number: 1
• Product Code: KMN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9121
• Other Device ID Number: 652308912181
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 84