MAUDE Adverse Event Report: CONSMA MECHANICAL WALKER, ROLLATOR; 890.3825

Model Number 65650R

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

Patient Problems Fall (1848); Discomfort (2330)

Event Type  No Answer Provided  

Event Description

End user reported that she was walking down two steps with her 65650r rollator, to get to the street, holding on to the railing.She fell, hit her head and hurt her shoulder.User went to physical therapy for 4-6 weeks.End user believes that the bus strapped it down too tight and she thinks it caused the wheels to fall off.User confirmed that the rollator did not malfunction and the wheels did not fall off at the time of the accident.She contacted her dealer and had it fixed.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): CONSMA; no. 158 huicheng rd; huimin ind; jianshan zhejiang 3141 12; CH 314112
• MDR Report Key: 4199037
• MDR Text Key: 17692206
• Report Number: 1531186-2014-05058
• 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: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/24/2014,06/30/2014

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: 65650R
• 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: 10/24/2014
• Distributor Facility Aware Date: 06/30/2014
• Device Age: 32 MO
• Date Report to Manufacturer: 10/24/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 86