MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS DUAL RELEASE JR. WALKER 9153629375; WALKER, MECHANICAL

Model Number 6291-JR

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Dealer states brand new out of box failure.Walker will not lock open it swings all the way around.Lot gt140831.No additional information available.

• Brand Name: DUAL RELEASE JR. WALKER 9153629375
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): GENTEEL HOMECARE PRODUCTS; liyu industry area; danzao nanhai foshan 5282 16; CH 528216
• MDR Report Key: 4449683
• MDR Text Key: 5426634
• Report Number: 1531186-2015-00542
• 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: 01/23/2015,01/16/2015

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: 6291-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: 01/23/2015
• Distributor Facility Aware Date: 01/16/2015
• Device Age: 5 MO
• Date Report to Manufacturer: 01/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other