MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE DEVILBISS HEALTHCARE; ADAPTOR, HYGIENE

Model Number	770-525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Limb Pain (4836)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath seat by the end user's son who stated the device's seat broke causing the end user to fall.The end user legs are weak and painful.The end user is having difficulty walking.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): COM-DA HEALTHCARE CO.,LTD; unit 3 no.94 dongcheng rd; dong sheng town; zhong shan city, guang dong province 52840 0; CH 528400
• MDR Report Key: 20044029
• Report Number: 2438477-2024-00043
• Device Sequence Number: 8117867
• Product Code: ILS
• UDI-Device Identifier: 00754021210336
• UDI-Public: 00754021210336
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2024
• Report Date (Section F): 08/22/2024

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: 770-525
• Device Catalogue Number: 770-525
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/06/2024
• Event Location: Home
• Date Report to Manufacturer: 08/22/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/22/2024