MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD WHEELCHAIR; WHEELCHAIR, MECHANICAL

Device Problems Defective Component (2292); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Stryker medical was notified of a potentially reportable complaint involving a product for which stryker is not the original equipment manufacturer of the reported device.The customer alleged a manufacturer medline wheelchair, serial number unknown with a cosmetically damaged armrest and a footrest that did not support weight.Please find additional contact information below.(b)(6).(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: WHEELCHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 17488353
• MDR Text Key: 320699078
• Report Number: MW5121052
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1