MAUDE Adverse Event Report: MED CHOICE; SHOWER CHAIR

Model Number 2867BTH231

Device Problem Collapse (1099)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 08/29/2016

Event Type  malfunction  

Event Description

Pt sitting on med choice shower chair washing up at sink.Chair leg collapsed and the pt fell hitting her hip and head.Event abated after use stopped or dose reduced? yes.

• Brand Name: MED CHOICE
• Type of Device: SHOWER CHAIR
• MDR Report Key: 5920443
• MDR Text Key: 53914555
• Report Number: MW5064475
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2867BTH231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Weight: 88