MAUDE Adverse Event Report: JUMAO HEALTHCARE EQUIPMENT VERANDA 20X16 IN FRAME W/DSK LNGTH REM ARMS W/ ELEV FTRST 9153651937; WHEELCHAIR, MECHANICAL

Model Number V20RLR

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Per end user father the back upholstery is tearing at the upholstery screw holes.

• Brand Name: VERANDA 20X16 IN FRAME W/DSK LNGTH REM ARMS W/ ELEV FTRST 9153651937
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JUMAO HEALTHCARE EQUIPMENT; jiashan ; CH
• MDR Report Key: 4431455
• MDR Text Key: 5413608
• Report Number: 1531186-2015-00381
• Device Sequence Number: 1
• Product Code: IOR
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/17/2015,01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V20RLR
• 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: 01/17/2015
• Distributor Facility Aware Date: 01/07/2015
• Device Age: 9 MO
• Date Report to Manufacturer: 01/17/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other