MAUDE Adverse Event Report: INVAMEX X2 RELEASE PADDLE WLKR-ADULT 9153641704; WALKER, MECHANICAL

Model Number G6291-1

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

End user stated that the g6291-1 walker given to him by the va is missing a tip and the set screw.

Manufacturer Narrative

(b)(4) - should additional information become available, a supplemental record will be filed.

• Brand Name: X2 RELEASE PADDLE WLKR-ADULT 9153641704
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4767753
• MDR Text Key: 5788600
• Report Number: 9616091-2015-01298
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/24/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G6291-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other