MAUDE Adverse Event Report: UNKNOWN TALL ADULT WALKLITE WALKER 9153643781; WALKER, MECHANICAL

Model Number UNKNOWN

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The end user states the right wheel on her walker broke off.She states the bolt broke causing the wheel to break and she fell scraping her arm while coming out of her grocery store.She states she puts an excessive amount of weight on the walker due to having multiple sclerosis.She states the model number and lot number are worn off.She states the front wheels are wide and they swivel.She states the walker is really old.Update from 11/18/2015: no medical intervention, minor scrape from alleged incident.No further information provided.

• Brand Name: TALL ADULT WALKLITE WALKER 9153643781
• 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: 5270130
• MDR Text Key: 33049007
• Report Number: 1525712-2015-05466
• 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: 11/12/2015

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: 11/12/2015
• Initial Date FDA Received: 12/07/2015
• 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