MAUDE Adverse Event Report: MAXHEALTH CORP. STEP 'N REST® ROLLING WALKER; ROLLATOR

Model Number FGA22300 0000

Device Problems Improper or Incorrect Procedure or Method (2017); Misassembly by Users (3133)

Patient Problems Laceration(s) (1946); Post Traumatic Wound Infection (2447)

Event Date 08/09/2015

Event Type  Injury  

Event Description

The user was going for a walk on (b)(6) 2015.As the user was walking, she went to go around some branches - just as she was going by some branches, one branch somehow got stuck up under the rollator.The metal piece on the left side of the rollator went into the user's left shin and made a huge gash.The user sat on the seat of the rollator and applied pressure to make the wound stop bleeding, but the pain was so bad, the user kept applying pressure to the wound.The user then went home and cleaned the wound, however, it was still hurting really bad - the user then went to her doctor.The doctor cleaned the wound and put medication on it.After a while, the wound was still hurting really bad, so the user's doctor sent her for an mri.The mri showed that the user had an infection in her bone.The user was put on an antibiotic to help get rid of the infection.The user still has a scar at the time the event was reported to (b)(4).(1/25/2016).The user had supplied a few photos of the rollator - it was found that the user actually had installed the back wheels of the rollator incorrectly.The wheel brakes (an l-shaped piece of metal that barely protrudes past the wheel; this piece of metal is meant to be applied to the wheel in order for the wheel to brake) were found to have been installed backwards - the l-shaped pieces of metal should be installed on the outside of the rollator, however, the user had installed the wheels with the l-shaped metal pieces on the inside of the rollator, which may have increased the possibility of the user being cut.

• Brand Name: STEP 'N REST® ROLLING WALKER
• Type of Device: ROLLATOR
• Manufacturer (Section D): MAXHEALTH CORP.; 15f-6, no. 81, sec. 1, hsin; tai wu road, hsi chih; taipei hsien, taiwan 221 ; TW 221
• MDR Report Key: 5455677
• MDR Text Key: 38853834
• Report Number: 2182780-2016-00001
• 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: Patient
• Type of Report: Initial
• Report Date: 02/23/2016,02/22/2016

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: FGA22300 0000
• Device Catalogue Number: FGA22300 0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/25/2016
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 02/23/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR