MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT MECHANICAL WALKER, ROLLATOR; 890.3825

Model Number 65851R

Device Problem Crack (1135)

Patient Problem Discomfort (2330)

Event Date 05/01/2014

Event Type  No Answer Provided  

Event Description

End user reported that the seat on her (b)(4) rollator is cracked, in three places, along with the handle used to lift the seat being cracked.User sustained pinching to her buttock(s).No alleged medical intervention.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL EQUIPMENT; danyang ; CH
• MDR Report Key: 4198961
• MDR Text Key: 20756025
• Report Number: 1531186-2014-05056
• 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: 10/24/2014,07/15/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 65851R
• 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: 07/15/2014
• Device Age: 63 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