MAUDE Adverse Event Report: REMEDA AB LOADING CAR

Model Number	15966-03
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris technician performed an inspection of the loading car and it was found that there was a "sharp edge" on the bottom side of the metal frame.A 3-year complaint review indicates this to be an isolated event.Steris has offered to file down the sharp edges on the loading car; we are pending the user facility's decision regarding the repairs.A follow-up mdr will be submitted should additional information become available.
Event or Problem Description
The user facility reported that an employee bumped their fingers into the bottom side of the metal frame of their loading car after placing a tray on the shelf.As a result the employee obtained a cut on two of their fingers; the employee received stitches and a bandage.The employee returned to work the same day.
Additional Manufacturer Narrative
In lieu of repairs, the user facility has received replacement loading cars.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: 17367493
• Report Number: 3013300766-2023-00001
• Device Sequence Number: 15304949
• Product Code: FLE
• UDI-Device Identifier: 07350109400069
• UDI-Public: 07350109400069
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023
• Report Date (Section F): 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15966-03
• Device Catalogue Number: 1596603
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 01/03/2024
• 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: 07/20/2023