MAUDE Adverse Event Report: COMPASS HEALTH BRANDS (CORPORATE OFFICE) CAREX BATH + SHOWER SEAT WITH BACK; CHAIR WITH CASTERS

Device Problem Break (1069)

Patient Problems Bruise/Contusion (1754); Fall (1848); Injury (2348)

Event Date 11/06/2019

Event Type  Injury  

Event Description

Caller stated that his spouse was using the bath chair when she was about to stand up the right rear leg of the chair collapsed and broke causing her to fall backwards to the floor.She was on the floor with her legs in the shower.He stated that he had helped to take her off the floor and placed her in the wheel chair.He stated that he noticed a bruise a few hours later, but she was not complaining about it.Caller stated that the bruised is all cleared up now.No medical attention was received.Caller stated that he returned the bath chair to the retailer and fill out a claim report.Caller stated that he was referred to contact the agency to file an incident report because this chair is a safety hazard.My wife was being given a shower by cna (b)(6).They showered and washed front side of her body.She then stoop up and back side was washed and rinsed off.Wife agnes sit back down to finish up.When agnes was helped up by cna (b)(6), rt rear leg broke on shower chair, agnes fell before she could reach handicap grips, landed left in shower back across step in and shoulder and head on the floor, ask her if she needed 911 and she replied no.But later she had bruises and scars on back, but healed up.My complaint is against faulty chair.Retailer: (b)(6).Retailer state: (b)(6).Purchase date: (b)(6) 2018.Document no: (b)(4).Report number: 20191119-89710-1921796.

• Brand Name: CAREX BATH + SHOWER SEAT WITH BACK
• Type of Device: CHAIR WITH CASTERS
• Manufacturer (Section D): COMPASS HEALTH BRANDS (CORPORATE OFFICE)
• MDR Report Key: 9575657
• MDR Text Key: 174678662
• Report Number: MW5092152
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR