MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD.; CAREX

Model Number FGA873C0 0000

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/03/2021

Event Type  Injury  

Event Description

I am a "hemiplegic" stroke paralyzed my left side.On (b)(6) 2021 11:00 pm walking from restroom the bottom part of leg went up inside top leg walker fell over i broke my shoulder had 3 surgeries couldn't use good arm had to spend 4 months in nursing home.I am home now in therapy.I purchased 3 of these.This one stayed in my bedroom i used it from my bed to wheelchair (5 ft) or from bed to my bathroom (15 ft) and back.The other 2 walkers are located in living room for walks, and in garage at the bottom of specially built stairs i use to walk to my car when my caregiver takes me to doctor appts.The other 2 walkers are ok but i'm scared to rely on them.(i have a 4th walker from another company that stays at back door.) she fell over and broke the humerus and shoulder on her good side.Landed her in a nursing home for 4 months.She's still in therapy for her shoulder.

• Type of Device: CAREX
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD.; no.61 & no.96, zhaoyi road, do; zhongshan city guangdong, 52841 4; CH 528414
• MDR Report Key: 17105815
• MDR Text Key: 317114114
• Report Number: 3012316249-2023-00017
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA873C0 0000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2023
• Distributor Facility Aware Date: 05/21/2023
• Device Age: 26 MO
• Event Location: Home
• Date Report to Manufacturer: 06/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 73 KG