MAUDE Adverse Event Report: DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. INVACARE MEDICAL; MECHANICAL (MANUAL) WHEELCHAIR

Model Number V20RFR

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

The caller states that the seams of the back upholstery are coming apart.

Manufacturer Narrative

Improve our sealing techniques, improved sealing strength.Responsible person: (b)(4), date: (b)(4) 2015.Training workers in upholstery workshop, make sure sealing process following sop.Responsible person: (b)(4), date: (b)(4) 2015.Update sip for the upholstery production, training the ipqc in workshop.Responsible person: (b)(4), date: (b)(4) 2015.

• Brand Name: INVACARE MEDICAL
• Type of Device: MECHANICAL (MANUAL) WHEELCHAIR
• Manufacturer (Section D): DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.; jiangsu province; danyang city,jiangsu province ; CH
• Manufacturer Contact: no. 36 danyan rd; jiangsu province; danyang city,jiangsu province 21230-0 ; 1186197009
• MDR Report Key: 4635137
• MDR Text Key: 15959406
• Report Number: 3004766495-2015-00048
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V20RFR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/14/2014
• Device Age: 8 MO
• Date Manufacturer Received: 11/20/2014
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other