MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS MECHANICAL WALKER, ROLLATOR; 890.3825

Model Number 68100-TA

Device Problem Unstable (1667)

Patient Problems Fall (1848); Discomfort (2330)

Event Date 10/30/2014

Event Type  No Answer Provided  

Event Description

Dealer stated that the 68100-ta rollator is wobbly left to right, unit cannot be tightened.End user reported that the rollator had been a little wobbly and he was using the unit with the seat down to try and make it more sturdy.User also reported that he missed a step outside a hotel and fell on the rollator, thus making the unit a lot more wobbly after the accident.User reported that his right knee was hurt due to the falling accident, was in the hospital for a day or two and then transferred to rehab for 10 days.He will require rehab in the home twice a week.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): GENTEEL HOMECARE PRODUCTS; liyu industry area; danzao nanhai foshan 5282 16; CH 528216
• MDR Report Key: 4242418
• MDR Text Key: 4990086
• Report Number: 1531186-2014-05516
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/11/2014,11/10/2014

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: 68100-TA
• 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: 11/11/2014
• Distributor Facility Aware Date: 11/10/2014
• Device Age: 5 MO
• Date Report to Manufacturer: 11/11/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other