MAUDE Adverse Event Report: REMEDA AB LOADING CAR

Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the guard rail to their loading car detached and fell onto an employee's foot resulting in a broken toe.Medical treatment sought and administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the loading car and found the unit to be operating properly; no repairs were required.Per discussion with user facility personnel, the technician learned that user facility personnel had removed the guard rails while loading instruments for a previous cycle.The employee incorrectly reinstalled their guard rail to the loading car resulting in the reported event.The technician counseled user facility personnel on the proper use and operation of their loading car, specifically properly installing the guard rail.No additional issues have been reported.

• Brand Name: LOADING CAR
• Common Device Name: LOADING CAR
• Manufacturer (Section D): REMEDA AB; transportvagen 8; halmstad, halland 30272 ; SW 30272
• MDR Report Key: 18380764
• Report Number: 3013300766-2023-00002
• Device Sequence Number: 7713322
• Product Code: FLE
• UDI-Device Identifier: 07350109400052
• UDI-Public: 07350109400052
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2023
• Report Date (Section F): 12/21/2023

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/21/2023