MAUDE Adverse Event Report: INVACARE CORP. INVACARE WHEELCHAIR; WHEELCHAIR, POWERED

Device Problem Component Missing (2306)

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 an invacare wheel chair, serial number (b)(6), needed left side arm and both brakes.Please find additional contact information below.(b)(6) this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INVACARE WHEELCHAIR
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE CORP.
• MDR Report Key: 17525503
• MDR Text Key: 321323046
• Report Number: MW5132444
• Device Sequence Number: 1
• Product Code: ITI
• 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: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1