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

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Event Description

Per importer's mdr: consumer alleges that he had a chair that the vinyl seat upholstery was pulling away from the hardware screws that fateb the upholstery to the frame.Consumer did not know if the chair was an invacare chair and had no additional information.

Manufacturer Narrative

There is no way to know whether this device was manufactured by a and i industries ltd.Since there was no model number provided and the device was not returned for evaluation.

• 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 AND I INDUSTRIES LTD.; lian du industry park; le liu town; shunde district, foshan city, guangdong ; TW
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 4954009
• MDR Text Key: 6257548
• Report Number: 9612393-2014-00045
• 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: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 52 YR
• Patient Weight: 98