MAUDE Adverse Event Report: VALENTINE INTL. LTD. CAREX; ROLLING WALKER

Model Number FGA22200 0000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

I bumped my leg with the rollator when i was taking it out of my car and got a very deep cut that required 5 stitches.It would be great if you had some kind of cover for the bolts on the wheels.I purchased it from riteaid in (b)(6) of 2021.I just want caps to cover the bolts on the wheels.I like the rollator.It's perfect for me, right height and okay to sit if i need to.User manual attached.The picture on the front cover shows end caps over the rear wheels but none for the front casters.It is unknown if the end-user received the laceration from the front casters or rear wheels.

Event Description

Device was returned for inspection.Inspection results: there is a stain on the seat tag.Unknown brown substance.Nonstandard handle grips are present on both sides.There are two screws protruding from the wheels that point toward the area the legs would be while walking or sitting.This was the source of the injury.This assembly does not look correct per our advertising product photos.Per the product photos the screw threads should face away from the frame and also have a cap attached from the manufacturer.Conclusion: a definitive root cause cannot be determined, however, from the information available this appears to be a assembly error that created a minor hazard to the user.It is unclear if the assembly was wrong from the manufacturer or was serviced by another party and not returned to its original assembly.The possibility of a service error taking place is present due to the brake handles being changed.

• Brand Name: CAREX
• Type of Device: ROLLING WALKER
• Manufacturer (Section D): VALENTINE INTL. LTD.; 8th fl., no. 149, sec. 2; ta tung rd.; hsichih city, taipei hsien 221 ; TW 221
• MDR Report Key: 15986714
• MDR Text Key: 305507823
• Report Number: 3012316249-2022-00016
• 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,Followup
• Report Date: 03/23/2023

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: FGA22200 0000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2023
• Distributor Facility Aware Date: 12/02/2022
• Device Age: 9 YR
• Event Location: Other
• Date Report to Manufacturer: 03/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 120 KG