MAUDE Adverse Event Report: INVAMEX S.DE R.L. DE C.V. WHEELCHAIR; WHEELCHAIR, MECHANICAL

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 tracer wheelchair serial number (b)(6), with reduced brake force.Please find additional contact information below.(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): INVAMEX S.DE R.L. DE C.V.
• MDR Report Key: 17488339
• MDR Text Key: 320710073
• Report Number: MW5121037
• 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