CAREX BATH + SHOWER SEAT WITH BACK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for CAREX BATH + SHOWER SEAT WITH BACK manufactured by Compass Health Brands (corporate Office).

Event Text Entries

[174678662] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092152
• MDR Report Key: 9575657
• Date Received: 2020-01-09
• Date of Report: 2020-01-09
• Date of Event: 2019-11-06
• Date Added to Maude: 2020-01-10
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CAREX BATH + SHOWER SEAT WITH BACK
• Generic Name: CHAIR WITH CASTERS
• Product Code: INM
• Date Received: 2020-01-09
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COMPASS HEALTH BRANDS (CORPORATE OFFICE)

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-09