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

Model Number	RTL12505
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss was notified of an incident involving a shower chair by the end user's wife who stated the shower chair shattered while in use.The end user fell and hit his head on the back of the tub and fell on his leg stump causing an open wound that required antibiotics.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: 19251867
• Report Number: 2438477-2024-00023
• Device Sequence Number: 6438011
• Product Code: ILS
• UDI-Device Identifier: 00822383247151
• UDI-Public: 822383247151
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/06/2024
• Report Date (Section F): 05/06/2024

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: RTL12505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/12/2024
• Event Location: Home
• Date Report to Manufacturer: 05/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2024
• 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: 56 YR
• Patient Sex: Male
• Date Report Sent to FDA: 05/06/2024