MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT DRIVE DEVILBISS HEALTHCARE; ADAPTOR, HYGIENE

Model Number	RTL12606
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath seat by an occupational therapist, who stated that the plastic part of the seat that holds the rear left leg broke off, causing the end user to fall.The end user, who had sustained a concussion ten months prior to the incident, reportedly began demonstrating symptoms again and sought medical attention.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.
Additional Manufacturer Narrative
Drive devilbiss healthcare previously reported the serial number as unknown for mdr 2438477-2025-00007.Section d4 has been updated with the serial number (b)(6).

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT; no.1318, tanjialing west road; ningbo, zhejiang 31540 0; CH 315400
• MDR Report Key: 21219042
• Report Number: 2438477-2025-00007
• Device Sequence Number: 14331996
• Product Code: ILS
• UDI-Device Identifier: 00822383525891
• UDI-Public: (01)00822383525891
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/24/2025
• Report Date (Section F): 01/24/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: RTL12606
• Device Catalogue Number: RTL12606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/23/2025
• Event Location: Home
• Date Report to Manufacturer: 01/24/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 01/24/2025
• 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: Other
• Patient Age: 61 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/24/2025