MAUDE Adverse Event Report: MAXHEALTH CORP. CAREX STEP N REST; ROLLATOR

Model Number FGA22300 0000

Device Problems Break (1069); Crack (1135)

Patient Problems Fall (1848); Injury (2348); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

The user is reported as having sat on the rollator, and the frame broke on one side - the user cannot say which side.The user fell and hit against the wall, and went down the floor.She is stating that she hurt her back, however, she has not sought medical attention; she did mention that she had hurt her back prior to this event as well, and may start water therapy.The user reports that she can't sleep since this has happened, and that she has trouble getting in and out of the shower.The user is reported as having been sitting on the rollator with the brakes engaged on concrete flooring.Her husband is reported as having checked the rollator regularly for maintenance.The user spoke with compass health brands' quality department on (b)(6) 2017, stating that she went to the doctor, and is now going to receive a call for physical therapy for her shoulder.She is currently using her brother's walker (rollator), but it is too heavy.She leans over to walk with the rollator - her legs have strength, but she has had three back surgeries, which is her reason for the rollator.The device involved with this event was returned to compass health brands and evaluated on 10/4/2017.The frame on the returned device was found to be cracked under the cross bar weld on the left rear (standard behind the unit) - as a result, the lower leg of the frame is only held on the hardware that keeps the unit from folding up.The customer's complaint could be confirmed from a review of the returned device.

• Brand Name: CAREX STEP N REST
• Type of Device: ROLLATOR
• Manufacturer (Section D): MAXHEALTH CORP.; 15f-6, no. 81, sec. 1, hsin; tai wu road, hsi chih; taipei hsien, 221 ; TW 221
• MDR Report Key: 6941602
• MDR Text Key: 89222085
• Report Number: 3012316249-2017-00123
• 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: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA22300 0000
• Device Catalogue Number: A223-00
• 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: 10/11/2017
• Distributor Facility Aware Date: 09/15/2017
• Event Location: Other
• Date Report to Manufacturer: 10/11/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 94