MAUDE Adverse Event Report: INVACARE INVACARE; WALKER, MECHANICAL

Device Problem Mechanical Problem (1384)

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 reported that multiple invacare folding walkers needed repairs.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: INVACARE
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17532459
• MDR Text Key: 321194273
• Report Number: MW5139367
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1