MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS DRIVE; BATH BENCH

Model Number	12011KD-1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident with a bath bench on (b)(6).The end-user stated that the leg of her bath bench broke while in use causing her to fall and hit her head.She "called the ambulance to assist her out of the tub and then take her to the hospital and they said a doctor will come to her home since the hospital was full." she has not returned the unit.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: BATH BENCH
• Manufacturer (Section D): BLISS HEALTH PRODUCTS; no.61 & no.96, zhaoyi road,; dongsheng town; zhongshan city, guangdong, 52841 4; CH 528414
• MDR Report Key: 13510613
• Report Number: 2438477-2022-00010
• Device Sequence Number: 5311729
• Product Code: ILS
• UDI-Device Identifier: 00822383224916
• UDI-Public: 822383224916
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2022
• Report Date (Section F): 02/10/2022

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: 12011KD-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/03/2022
• Device Age: 13 MO
• Event Location: Home
• Date Report to Manufacturer: 02/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2022
• 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: Other
• Patient Sex: Female
• Patient Weight: 154 KG
• Date Report Sent to FDA: 02/10/2022