MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; UNKNOWN WALKER DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Fracture, Arm (2351)

Event Date 11/02/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the end-user, a (b)(6) amputee, fell while using a walker that she believed to be manufactured by medline industries, inc.Reportedly, the end-user was ascending a ramp into her home when the left-sided hand-hold of the walker "failed." reportedly, "the left release rivet tore through the metal stay-bar." the end-user fell onto an unidentified side and onto an unidentified surface.It is unknown how the end-user was able to get back up after this fall or if she went to a hospital, emergency department, or doctor's office immediately following the incident.After an unidentified period of time, the end-user was reportedly diagnosed with a fracture to an unidentified arm and was required to have surgery.No specific diagnostic exams were reported to the manufacturer.The reported surgery was not identified and information regarding the date of the surgery was not provided to the manufacturer.No sample was returned to the manufacturer for evaluation.An invalid item number was provided to the manufacturer.No product item number or lot number was reported to indicate the walker is a medline industries, inc.Device.Photos of the walker involved in the incident did not provide information to confirm it to be a medline industries, inc.Device.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that an end-user fell while using a walker that she believed to be manufactured by medline industries, inc.The end-user experienced a fracture to an unidentified arm which required an unidentified surgery.

• Type of Device: UNKNOWN WALKER DEVICE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 7526927
• MDR Text Key: 108690591
• Report Number: 1417592-2018-00038
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/18/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR