MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD DRIVE DEVILBISS HEALTHCARE; ADAPTOR, HYGIENE

Model Number	RTL12203KDR
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss was notified of an incident involving a bath seat by the provider who stated that the thread components of the frame had disintegrated.The end user turned to adjust herself to get out of the shower when the front and back legs collapsed, causing the end user to fall on her left arm.The end user went to the hospital and was diagnosed with a fracture to arm.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO. LTD; no.61 &96 zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 19787013
• Report Number: 2438477-2024-00038
• Device Sequence Number: 8429100
• Product Code: ILS
• UDI-Device Identifier: 00822383246253
• UDI-Public: 00822383246253
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2024
• Report Date (Section F): 07/19/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RTL12203KDR
• Device Catalogue Number: RTL12203KDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/03/2024
• Event Location: Home
• Date Report to Manufacturer: 07/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2024
• 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 Age: 79 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/19/2024