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

Model Number V18RFR

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer advised seat upholstery is coming apart at the seams.

Manufacturer Narrative

Concerning the alleged issue, we have improve our sewing techniques, this will not happen any more 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.; danyang city,jiangsu province ; CH
• Manufacturer Contact: no.36 danyan road; danyang city,jiangsu province 21230-0 ; 1186197666
• MDR Report Key: 4638797
• MDR Text Key: 19603940
• Report Number: 3004766495-2015-00025
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V18RFR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/08/2014
• Device Age: 5 MO
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other