MAUDE Adverse Event Report: TAIWAN AN I CO.,LTD. MECHANICAL (MANUAL) WHEELCHAIR

Model Number IN88AHANFR

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Per importer's mdr: it was reported that the upholstery is coming apart at the seam.

• Brand Name: MECHANICAL (MANUAL) WHEELCHAIR
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): TAIWAN AN I CO.,LTD.; no.1 been ting been-tsuoh; village, shi-koou shiang; chia-yi shiann ; TW
• Manufacturer (Section G): A & I INDUSTRIES LTD. ; lian du industry park; le liu town, shunde dist.; foshan city, guangdong ; TW
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 6199795
• MDR Text Key: 63638630
• Report Number: 9612393-2014-00018
• 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: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IN88AHANFR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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