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

Model Number 65100R-JR

Device Problems Bent (1059); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2014

Event Type  No Answer Provided  

Event Description

Dealer alleged that the front leg was bent inward when received.

• 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: 3929697
• MDR Text Key: 4534936
• Report Number: 1531186-2014-02496
• 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: 07/11/2014,06/06/2014

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-JR
• 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: 07/11/2014
• Distributor Facility Aware Date: 06/06/2014
• Device Age: 3 YR
• Date Report to Manufacturer: 07/11/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other