MAUDE Adverse Event Report: UNKNOWN DUAL RELEASE FOLDING WALKER 9153638082; WALKER, MECHANICAL

Model Number UNKNOWN

Device Problems Hole In Material (1293); Naturally Worn (2988)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

End user is stating that the sure glide brakes are wearing, and not working properly.End user is stating he has had the unit since 2003, and from wear there is now a hole in the bottom of the glide brake.

• Brand Name: DUAL RELEASE FOLDING WALKER 9153638082
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5049581
• MDR Text Key: 25491552
• Report Number: 1525712-2015-04444
• 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
• Report Date: 08/03/2015

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• 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