MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD AQUASENSE; BATHTUB BENCH

Model Number	770-420
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
End user fell in the bath tub while using the unit and suffered some minor bruising.The unit collapsed causing her to fall into the tub while under supervision of her caregiver.She sought no medical attention because the caregiver was there to help, but she is sore and bruised.No additional information is available.The tightening mechanism split.

• Brand Name: AQUASENSE
• Common Device Name: BATHTUB BENCH
• 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: 13595244
• Report Number: 3014644996-2022-00004
• Device Sequence Number: 19494727
• Product Code: ILS
• UDI-Device Identifier: 00754021215928
• UDI-Public: 754021215928
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/23/2022

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: 770-420
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 02/24/2022
• 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: Female