MAUDE Adverse Event Report: GF HEALTH PRODUCTS, INC. LUMEX; CHAIR, ADJUSTABLE, MECHANICAL

Model Number 7921A-4

Device Problem Mechanical Problem (1384)

Patient Problems Fall (1848); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/02/2022

Event Type  malfunction  

Event Description

Patient was in shower seated on shower chair.Patient's husband was present and providing assist to the patient at the time of the event.Patient was seated and was finishing up drying off when the rear right leg of the shower chair buckled causing patient to fall.Patient denied hitting head and caught herself on her left hand which was sore.Patient fall score was 3 making patient a low fall risk.Patient complained of soreness to left wrist, left knee, and neck.Xray of left knee, left hand, and cervical spine completed.No fractures noted with any of the images.Patient did require modifications to pain management with addition of stronger/more pain medications, ice, elevation, and wrapping and splinting of left wrist.Device has weight limit of 350 lbs with a printed label on the chair.

• Brand Name: LUMEX
• Type of Device: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): GF HEALTH PRODUCTS, INC.; 1 graham field way; atlanta GA 30340
• MDR Report Key: 15461803
• MDR Text Key: 300311974
• Report Number: 15461803
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7921A-4
• Device Catalogue Number: 7921A-4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Female
• Patient Weight: 141 KG
• Patient Race: White