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

Model Number	RTL12505
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Per mdr #2438477-2024-00030: drive devilbiss healthcare was notified of an incident involving a bath seat by a provider, who reported the end user was using the bath seat when the chair collapsed.The nature of the collapse has not been specified to date.The end user was reportedly admitted to the hospital with injuries caused by the incident, however, the injuries have not been specified to date.Drive attempted to contact the provider on several occasions regarding the incident and the product, however did not receive any further information.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: BATH SEAT
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong 52840 0; CH 528400
• Manufacturer (Section G): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong 52840 0; CH 528400
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7202545756
• MDR Report Key: 19527056
• Report Number: 3014644996-2024-00010
• Device Sequence Number: 7575313
• Product Code: ILS
• UDI-Device Identifier: 00822383247151
• UDI-Public: 00822383247151
• 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: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: RTL12505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male