MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; WALKER,GUARDIAN,W/5IN WHEEL,ADULT

Catalog Number G30757WH

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Hip Fracture (2349)

Event Date 06/15/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the customer was at home independently standing up from the commode when a wheel broke off of the walker and the customer fell to the ground, resulting in the customer sustaining a fractured right hip.The medical supply company stated that the emergency room records show that the patient was admitted to the hospital after the fall with a diagnosis of right hip pain and a dislocated right hip which led to a right hip revision surgery on (b)(6) 2019.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer was unable or unwilling to provide further patient, or incident details to the manufacturer.A sample has not been returned to the manufacturer for evaluation.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that the wheel broke off of the walker and the customer fell to the ground resulting in a fractured hip.

• Type of Device: WALKER,GUARDIAN,W/5IN WHEEL,ADULT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 9100932
• MDR Text Key: 162002410
• Report Number: 1417592-2019-00162
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: G30757WH
• Device Lot Number: 88518030002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/20/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 61