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

Model Number 65100R

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2014

Event Type  No Answer Provided  

Event Description

Dealer advised push nut or retention washer is missing from the right side.

Manufacturer Narrative

(b)(4).- correction to initial manufacturer report # 1531186-2014-05319.Type of report, did not indicate initial report, therefore, did not reflect initial report on the 3500a report.

• 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: 4224007
• MDR Text Key: 5071994
• Report Number: 1531186-2014-05319
• 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,Followup
• Report Date: 11/03/2014,10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 65100R
• 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: 11/03/2014
• Distributor Facility Aware Date: 10/15/2014
• Device Age: 22 MO
• Date Report to Manufacturer: 11/03/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other