MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; WALKER

Catalog Number G30757W

Device Problem Insufficient Information (3190)

Patient Problem Suture Abrasion (2497)

Event Date 04/16/2016

Event Type  Injury  

Manufacturer Narrative

While using the walker in the house, he turned the device and the right side of the walker broke.He fell and suffered two lacerations around his right eye.The lacerations were repaired with sutures.The sample has not been returned for evaluation.An incorrect lot number was provided.The fall was not witnessed.It is unknown if the end user fell causing the right side of the walker to break or if the right side breaking contributed to the end user falling.No additional information was provided regarding the incident.In the absence of a sample and lot number, a root cause has not been determined.However, due to the reported injury and in an abundance of caution, this medwatch is being filed.

Event Description

The end user fell when he turned the device.

• Type of Device: WALKER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5659522
• MDR Text Key: 45312141
• Report Number: 1417592-2016-00058
• 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: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: G30757W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/17/2016
• 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
• Patient Age: 74 YR
• Patient Weight: 107