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

Model Number	RTL12202KDR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath bench by the end user's husband, who stated that during use, one of the chair's legs reportedly folded under, causing the chair to collapse.The end user reportedly sustained a cut and bruise on her left leg and a swollen left ankle, and was later prescribed antibiotics.If additional pertinent information becomes available, a follow-up medical device report will be submitted.

• 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: 18016212
• Report Number: 2438477-2023-00138
• Device Sequence Number: 6539129
• Product Code: ILS
• UDI-Device Identifier: 00822383247212
• UDI-Public: 00822383247212
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2023
• Report Date (Section F): 10/26/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RTL12202KDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/27/2023
• Event Location: Home
• Date Report to Manufacturer: 10/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2023
• 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: 78 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/26/2023