MAUDE Adverse Event Report: COM-DA HEALTHCARE CO., LTD PROBASICS; 8" BURGUNDY TRANSPORT ROLLATOR

Model Number RLATBG

Device Problem Use of Device Problem (1670)

Patient Problem Hip Fracture (2349)

Event Date 09/30/2023

Event Type  Injury  

Event Description

Her mother-in-law has had device for maybe 6 months.She was sitting on it, they pushed her, it folded up and she fell and broke her hip and had surgery.Wants to know who to talk to before calling an attorney.Couldn't find serial # and said would get back to us with it.Said she has spoken to 2 attorneys and they said for her to reach out to us first.Stated the event occurred last day in september.She hasn't been able to come home since this happened.She was sitting, they were using it like a wheelchair.Pushed her about 10 feet and it folded up with her sitting on it.Her legs got tangled, she caught her shoulder so she wouldn't hit her head, but couldn't get the rest and hit her hip and broke her hip replacement in the bone.Took her to hospital and stayed 4 days then transferred to rehab facility because they were afraid to do surgery due to age.Stayed 6 days there, doctor came and said it's impacted and displaced that she needed to go to er.She was taken to hospital, with am, in er for 2 days (they couldn't do the surgery) then transferred to saint vincent in where they took her into surgery and they put in plate and screws.Then due to surgery her kidneys failed a couple days later.She was transferred to acute rehab to see if she could walk again.Stayed 3 1/2 weeks there, then transferred to sub-acute facility so she could get dialysis and now she got covid in the facility.She'll be (b)(6) on (b)(6) 20th.She is still in facility.Prior to this she walking, dressing herself, her whole life has changed since this fall.Device shouldn't have folded with her on it.She weighs much less than 160 lbs.Now.It didn't break, just folded up.She will try to find the receipt for it or the bank statement.Had surgery around (b)(6) 12th.Her husband (end users son) was pushing her, she was next to them.They were outside a strip mall, pushing her to go up the wheelchair ramp, didn't get to the ramp before it folded up.She cannot get up, nothing now.She cannot do therapy now because of covid, hoping she makes it through it.The rollator looks fine, it just folded up.Device was requested to returned, csr stated she would get a refund or replacement for device.She stated she deserves a lot more than that.Stated until she talks to someone else she will not return the device to us.Stated she will probably end up in a nursing home because of this.Csr stated she should hear from someone within 24-48 hours.Hang tag attached.Page 5, operating instructions, unfolding your rollator: "1.With all wheels touching the ground, gently pull the frame apart until the folding hinge is completely straightened on both sides (fig.A).Ensure the rollator is fully opened, the seat is down and the backrest is locked in before use." page 10, first bulletin: "· always make sure the rollator is fully opened and the folding bar is locked in the down position before use.".

• Brand Name: PROBASICS
• Type of Device: 8" BURGUNDY TRANSPORT ROLLATOR
• Manufacturer (Section D): COM-DA HEALTHCARE CO., LTD; no. 1, jinzhao street, west di; no. 6 workshop ii; zhongshan city guangdong, cn ; CH
• MDR Report Key: 18569970
• MDR Text Key: 333554579
• Report Number: 3012316249-2024-00001
• 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: 01/24/2024

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: RLATBG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2024
• Distributor Facility Aware Date: 01/03/2024
• Device Age: 20 MO
• Date Report to Manufacturer: 01/24/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 96 YR
• Patient Sex: Female
• Patient Weight: 73 KG