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

Model Number	RTL12202KDR
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Limb Pain (4836)
Date of Event	01/01/2024
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, who reported that the leg of the device broke while in use causing her to fall.She reportedly "hit her left hip and hurt her lower back where [a prior] surgery was" and "is in excruciating pain, she cannot move at all, can't lift her legs, spread her legs apart." drive devilbiss healthcare is currently investigating the incident.An update will be filed if additional information becomes available.

• Brand Name: DRIVE
• 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: 18547528
• Report Number: 2438477-2024-00005
• Device Sequence Number: 8925797
• Product Code: ILS
• UDI-Device Identifier: 00822383247212
• UDI-Public: 00822383247212
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/19/2024
• Report Date (Section F): 01/19/2024

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: RTL12202KDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/04/2024
• Event Location: Home
• Date Report to Manufacturer: 01/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2024
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 115 KG
• Date Report Sent to FDA: 01/19/2024