MAUDE Adverse Event Report: INVAMEX MAXI PLUS LOW BLUE 7331492560462; WALKER, MECHANICAL

Model Number 12122-37-746

Device Problem Bent (1059)

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

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Event Description

Frame is bent by caster.

Event Description

Frame is bent by caster.Per a communication with invacare (b)(4), it is confirmed that the frame is bent.The unit has been scrapped.This was received back at invacare (b)(4) on 6/10/2016.

• Brand Name: MAXI PLUS LOW BLUE 7331492560462
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5716710
• MDR Text Key: 47237624
• Report Number: 9616091-2016-00837
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 12122-37-746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2016
• Initial Date FDA Received: 06/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1