MAUDE Adverse Event Report: MAXHEALTH CORP. PROBASICS; BARIATRIC ALUMINUM ROLLATOR

Model Number RLAB8BG

Device Problem Material Separation (1562)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

Consumer was sitting in the rollator.Front wheel came off and sent him over the rollator.Fractured his shoulder and #4 rib.Paramedics were called.Did not go to hospital.Went to doctor and had x-rays done.He has degenerative disk in his back is why the hospital gave him a rollator 2 months ago which he uses to be mobile.Back injury due to motorcycle accident.Son called to make a claim for his father.Returning to the doctor on december 5th for follow up visit.

• Brand Name: PROBASICS
• Type of Device: BARIATRIC ALUMINUM ROLLATOR
• Manufacturer (Section D): MAXHEALTH CORP.; 14f, no. 99, section 1; xintai 5th road; xizhi district new taipei city, 22102 ; TW 22102
• MDR Report Key: 9375503
• MDR Text Key: 168581431
• Report Number: 3012316249-2019-00040
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RLAB8BG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/26/2019
• Distributor Facility Aware Date: 11/08/2019
• Date Report to Manufacturer: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 151