MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT ALUM.TRANSPORT WC 12 INWLS RED 9153643816; WHEELCHAIR, MECHANICAL

Model Number ALR19HBFR

Device Problems Product Quality Problem (1506); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2014

Event Type  malfunction  

Event Description

It has been reported that an alr19hbfr transport chair was received with damaged/scratched canes.

• Brand Name: ALUM.TRANSPORT WC 12 INWLS RED 9153643816
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL EQUIPMENT; danyang ; CH
• MDR Report Key: 4348567
• MDR Text Key: 5216643
• Report Number: 1531186-2014-06575
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/18/2014,11/06/2014

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: ALR19HBFR
• 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: 12/18/2014
• Distributor Facility Aware Date: 11/06/2014
• Device Age: 11 MO
• Date Report to Manufacturer: 12/18/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other