MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE; BATH CHAIR

Model Number	RTL12505
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare received a complaint involving a bath chair from an end user, who stated that "the leg of the bath chair collapsed, and he suffered a strain in his thigh muscle." the end user did not seek any medical treatment.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: BATH CHAIR
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west di; no. 6 workshop ii; zhongshan city, guangdong ; CH
• MDR Report Key: 17209393
• Report Number: 2438477-2023-00024
• Device Sequence Number: 5684142
• Product Code: ILS
• UDI-Device Identifier: 00822383247151
• UDI-Public: 00822383247151
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2023
• Report Date (Section F): 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RTL12505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/23/2023
• Date Report to Manufacturer: 04/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 127 KG
• Date Report Sent to FDA: 04/11/2023