MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CAREVO; LIFT, PATIENT, NON-AC-POWERED

Model Number	BAC1111-01
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Arjo was notified of an event involving a carevo shower trolley.It was indicated that the side support had opened, causing the patient to fall from the device.As a result, the patient sustained an injury to the lips, which were bleeding.This required three stitches to be applied.

• Brand Name: CAREVO
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 20406128
• Report Number: 1419652-2024-00061
• Device Sequence Number: 6422943
• Product Code: FSA
• UDI-Device Identifier: 05055982787178
• UDI-Public: (01)05055982787178(11)220913
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2024
• Report Date (Section F): 10/09/2024

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: Other
• Device Model Number: BAC1111-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/12/2024
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/09/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/09/2024