MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL CAREX; HEIGHT ADJ. ROLLATOR, PINK

Model Number FGA61700 0000

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Laceration(s) (1946); Vertebral Fracture (4520)

Event Date 09/17/2022

Event Type  Injury  

Event Description

User said item purchased on (b)(6) 2022 from amazon.User was at a concert sitting on the rollator on (b)(6) 2022 when the front right wheel (caster) fell off and the user fell backwards falling on her back.User said she cut her arm and was bleeding.She also ended up receiving a stress fracture on her lumbar spine.Said she went to her doctor after the accident to review an mri and that is how she found out about the back injury.180 lbs.Is user weight.User said she has not scooted around on the unit previously.My son managed to get the wheel back on, however i am now scheduled for a 2nd spine surgery, mri shows slight fracture of my si joint due to a hard fall.I only noticed yesterday that the same wheel which fell off is now bent and the walker is very dangerous to use as i cannot trust falling again.User called back and said she is physically unable to fold up defective walker to fit it in a box and have it returned.She is unable to get anyone to help her.Had previous back surgery.When she went to her surgeon he asked "did you take a major fall" and she said yes she did and has a video of it and he said "well that's probably what did it".Said she's not looking to sue anybody, she just wants to be safe, but if she really wanted to go to her attorney she could but she doesn't want to.This occurred at the stevie nicks concert.She needs to use the rollator again since she is having surgery again and that is why she just now contacted us.She was cut on her arm at the time and then found out she has a stress fracture in her s i joint.She was in pain from previous issue and didn't know she was in pain from this.Her previous surgery was on her l3, l4, and l5 of lumbar and the stress fracture is right below it.She went to her surgeon and then he sent her to pain management.She is now going to have the new surgery, reluctantly, because she is doing more damage to herself by not having it.Said she only ever used it to walk in her house, never sat/scooted.Says she really loves it and just thinks it was a defective wheel.

• Brand Name: CAREX
• Type of Device: HEIGHT ADJ. ROLLATOR, PINK
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL; no. 1, chuangye street, southw; matou ecological industry park; handan city hebei, cn 05604 6; CH 056046
• MDR Report Key: 16867490
• MDR Text Key: 314619129
• Report Number: 3012316249-2023-00008
• 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: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA61700 0000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2023
• Distributor Facility Aware Date: 04/13/2023
• Device Age: 28 MO
• Event Location: Other
• Date Report to Manufacturer: 05/04/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 82 KG