MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC WALKER

Catalog Number G30757W

Device Problem Break (1069)

Patient Problems Wound Dehiscence (1154); Injury (2348)

Event Date 09/03/2014

Event Type  Injury  

Event Description

While standing to use the walker the wheel broke and the end user fell.

Manufacturer Narrative

The facility reported that while the end user stood to use the walker, the left wheel broke and she fell.She suffered a dehiscence of her knee incision.She was taken to surgery to have the wound closed.Two leg extensions with wheels were returned by the facility for evaluation.The wheels on both returned leg extensions were bent and cracked.No voids were present on the fractured wheel.There is no evidence of any manufacturing defect.The walker was not returned and its overall condition is not known.It is unclear if this device had been used by multiple pts during the two years after it had been manufactured.Care and maintenance is not known.A root cause has not been determined.

• Brand Name: WALKER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4297367
• MDR Text Key: 5079225
• Report Number: 1417592-2014-00107
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2014

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
• Device Lot Number: C121218224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/23/2014
• Initial Date FDA Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 81