MAUDE Adverse Event Report: CONSMA RED ADULT ROLLATOR WITH BASKET 9153647190; WALKER, MECHANICAL

Model Number 65851R

Device Problem Crack (1135)

Patient Problem Discomfort (2330)

Event Type  Injury  

Event Description

Dealer stated that the end users son reported that the seat on his mothers 65851r rollator has been cracked for some time and has pinched his mothers bottom.

• Brand Name: RED ADULT ROLLATOR WITH BASKET 9153647190
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): CONSMA; no. 158 huicheng rd; huimin ind; jianshan zhejiang ; CH
• MDR Report Key: 4383672
• MDR Text Key: 19353704
• Report Number: 1531186-2015-00013
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/05/2015,12/26/2014

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: 01/05/2015
• Distributor Facility Aware Date: 12/26/2014
• Device Age: 2 YR
• Date Report to Manufacturer: 01/05/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other