MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT ECONOMY ROLLATOR W/HAND BRAKE W/CURVE BKRST 9153644547; WALKER, MECHANICAL

Model Number 65650

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Fall (1848)

Event Date 09/01/2014

Event Type  Injury  

Event Description

End user reported that she has fallen many times through no fault of her (b)(4) rollator.She stated that she fell in (b)(6) 2014, skinned her left knee and her (b)(4) rollator was scratched up, one wheel off the ground and the seat moved back and forth.This event was no fault of the rollator.End user has an issue with her back and needs surgery, not sure when she will be getting back surgery.End user advised she continued to use the rollator.She will now contact a dealer for a new unit.No alleged medical intervention.

• Brand Name: ECONOMY ROLLATOR W/HAND BRAKE W/CURVE BKRST 9153644547
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL EQUIPMENT; danyang ; CH
• MDR Report Key: 4468177
• MDR Text Key: 16468212
• Report Number: 1531186-2015-00674
• 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
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/29/2015,01/27/2015

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: 65650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2015
• Distributor Facility Aware Date: 01/27/2015
• Device Age: 14 MO
• Date Report to Manufacturer: 01/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other