MAUDE Adverse Event Report: RALON MEDICAL EQUIPMENT CO., LTD. COMPASS HEALTH BRANDS; VOYAGER ROLLATOR

Model Number RLEU10PK

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/22/2024

Event Type  Injury  

Event Description

Voyager having wheel problems and it caused a spill for her mother.She looked up and saw a recall for the device.Wheels are "shaking and stuff" and it caused her mom to trip and cracked her ribs.She went to the hospital, she's in her 90's so any fall is threatening at that age.Looked up and saw a class ii recall.She is in an assisted living facility and she bought the device for her.She was coming out of an elevator and the wheels wobbled and she couldn't go forward and fell to the side and unfortunately there was a chair there with a wooden arm on her ribs and cracked her rib, a fracture.She's on pain meds but nothing else they can do for it.This happened on (b)(6) 2023, at the living facility during mid-day when she went down to get her mail.Weighs 90 lbs.And is (b)(6) years old.Questioned the recall again.Csr stated she would need the recall form completed.Stated someone would reach out to her about the injury.The device listed in this case was not part of the recall nor was the recall for this issue.The recall was for wheel spokes failing and included serial numbers (b)(6)- (b)(6).Inspection findings: this alleged injury is in no way related to the voyager recall, even though the item was produced during the same time period.No product defect was found outside of cosmetic damage.The wheels do not wobble when walking at a casual pace and could only be made to wobble a small amount while at a slow jog.The complaint in this case could not be duplicated.We were unable to get the wheels to wobble to a degree that it had any impact on the product's ability to remain upright.A definitive root cause could not be determined in this case with the information available.Upon return the device does not exhibit a malfunction which could result in sudden tipping.It is more likely that the threshold for the elevator was uneven, which is extremely common, and this difference in elevation presented an obstacle the user could not handle with their level of balance and physical strength.There was already a warning present for this in the user manual.This product has since been discontinued.

• Brand Name: COMPASS HEALTH BRANDS
• Type of Device: VOYAGER ROLLATOR
• Manufacturer (Section D): RALON MEDICAL EQUIPMENT CO., LTD.; xilian development zone jinsha; foshan guangdong, cn 52822 2; CH 528222
• MDR Report Key: 18787724
• MDR Text Key: 336315057
• Report Number: 3012316249-2024-00004
• 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: 02/27/2024

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: RLEU10PK
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2024
• Distributor Facility Aware Date: 02/01/2024
• Device Age: 35 MO
• Date Report to Manufacturer: 02/27/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 96 YR
• Patient Sex: Female
• Patient Weight: 41 KG