MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD ALUM.TRANSPORT WC 12 INWLS RED 9153643816; WHEELCHAIR, MECHANICAL

Model Number TRAN19FR

Device Problems Detachment Of Device Component (1104); Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Upholstery coming apart at the seam.

Event Description

Upholstery coming apart at the seam.

Manufacturer Narrative

(b)(4).This is a (b)(6) event, with a (b)(6) dealership location.

• Brand Name: ALUM.TRANSPORT WC 12 INWLS RED 9153643816
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD; yunyang industrial park; danyang city; jiangsu pro ; CH
• MDR Report Key: 4424960
• MDR Text Key: 5282108
• Report Number: 1531186-2015-00295
• 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,Followup
• Report Date: 01/16/2015,12/31/2014

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: TRAN19FR
• 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: 01/16/2015
• Distributor Facility Aware Date: 12/31/2014
• Device Age: 5 MO
• Date Report to Manufacturer: 01/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other