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

Model Number	RTL12505
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare was notified on an incident involving a bath safety device on (b)(6).While using the unit the patient fell in bathtub exacerbating an existing broken ankle.On (b)(6) the end-user's mother reported "my son went to the doctor and had a plaster cast put on his leg at the appointment that we discussed, however he is experiencing some further issues and has to return to the doctor on (b)(6) 2021 to address the pain and try to find the cause of the increased difficulty at this time".The patient was prescribed tramadol for pain.The unit has not been returned for evaluation and no additional information is available at this time.Drive devilbiss healthcare is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update as soon as additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: SHOWER CHAIR
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer (Section G): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 15476402
• Report Number: 3014644996-2022-00013
• Device Sequence Number: 6020725
• Product Code: ILS
• UDI-Device Identifier: 00822383247151
• UDI-Public: 822383247151
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 113 KG