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

Model Number	RTL12505
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Muscle/Tendon Damage (4532)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
From drive devilbiss: drive devilbiss healthcare is the initial importer of the device which is a bath safety device.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.A follow-up submission will be filed when additional information is available.The front leg of the bath safety device snapped off while in use.The user fell on his left side.When his wife returned home she took him to the emergency room.They took x-rays and diagnoses muscle tears.He was prescribed pain medicine and steroids.

• Brand Name: DRIVE
• Common Device Name: BATH SAFETY DEVICE
• 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: 13650176
• Report Number: 3014644996-2022-00007
• Device Sequence Number: 2304893
• Product Code: ILS
• UDI-Device Identifier: 00822383247151
• UDI-Public: 822383247151
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/02/2022

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: 03/02/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Male