MAUDE Adverse Event Report: GF HEALTH PRODUCTS INC. LUMEX, CONTOUR DELUXE ROLLATOR

Model Number SET N'GO, RJ4700

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Fall (1848); Pain (1994); Sprain (2083); Weakness (2145)

Event Date 07/28/2017

Event Type  Injury  

Event Description

The seat on the rollator is designed to swing up or down.To accomplish this the seat is hinged across one end (numbered 2 on the attached picture of the rollator) and free to swing up or down on the opposite end.The free moving end of the seat rest upon the rollator frame assembly (numbered 1 on the attached picture of the rollator).While sitting on the seat of the rollator the aluminium tubing seat support member (#1) broke off sending me backwards onto the floor onto my back, my legs pointed straight to the ceiling.For several years i have had back pain, mostly in the morning, in an area to the left of my lower back.I have taken exercises under professional guidance, and later on back surgery.None of these approaches resulted in relief.The results of this product failure is that i now have this same type of pain across my lower back.I also have the weakening of my legs to where i must immediately sit down.This is a carryover yet at a stronger level.To recreate the scene, the component marked as (3) was removed and i was sitting facing in the direction of ("3").Without a bit of warning the component marked (1) gave completely away, dropping the back of the seat and me downward to the floor.Examination of component #1 indicated that the aluminium tubing ripped, both sides, just above a welded joint holding component #1 into fittings #4.Injury information: injury, no first aid or medical attention received.Location of injury: arm.Type of injury: strain, sprain.Purchased from: (b)(6).May we include your report including any documents or photographs that you have attached to your reports, but without your name and contact information, in (b)(6) public database: yes.May we release your name and contact information to the product manufacturer or private labeler: yes.

• Brand Name: LUMEX, CONTOUR DELUXE ROLLATOR
• Type of Device: LUMEX, CONTOUR DELUXE ROLLATOR
• Manufacturer (Section D): GF HEALTH PRODUCTS INC.
• MDR Report Key: 6879288
• MDR Text Key: 86976069
• Report Number: MW5072219
• Device Sequence Number: 0
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: SET N'GO, RJ4700
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2017
• Type of Device Usage: N
• Patient Sequence Number: 1