MAUDE Adverse Event Report: UNITED PLASTIC MOLDERS, INC. THE AFTERMARKET GROUP; SECURE AUTOMATIC WHEEL LOCK KIT

Device Problem Fail-Safe Design Failure (1222)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 09/04/2016

Event Type  Injury  

Event Description

Safety device that holds the nut in place that connects brakes to wheelchair did not keep nut in place despite following manufacturer's installation instructions.Position of bolt allows torque from brakes to loosen nut beyond the positioning of the safety cap that covers the nut.Wheel fell off wheelchair causing fall with head injury.All of these same brakes are removed from other wheelchairs.Upon removal of these same brakes from other wheelchairs, the nut was loose behind each of the orange safety caps.It appears that the orange safety cap covers approximately 1/4 inch or less of the bolt and the torque from braking results in a loosened nut with that doesn't engage the 1/4 inch of protection.

• Brand Name: THE AFTERMARKET GROUP
• Type of Device: SECURE AUTOMATIC WHEEL LOCK KIT
• Manufacturer (Section D): UNITED PLASTIC MOLDERS, INC. ; jackson MS
• MDR Report Key: 5952916
• MDR Text Key: 54922003
• Report Number: 5952916
• Device Sequence Number: 1
• Product Code: KNO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2016
• Distributor Facility Aware Date: 09/04/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/09/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 91 YR
• Patient Weight: 54