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

Model Number	RTL12202KDR
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare received a complaint involving a bath bench from an end user, who reported that "while sitting on the chair the left back leg bent" causing him to fall and sustain "lacerations above his elbow and abrasions on his forearms." x-rays and a ct-scan were negative.The end user disposed of the chair, which therefore cannot be returned for evaluation.

• Brand Name: DRIVE
• Common Device Name: BATH BENCH
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO. LTD; no.61 & no.96, zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 15364673
• Report Number: 2438477-2022-00058
• Device Sequence Number: 20452589
• Product Code: ILS
• UDI-Device Identifier: 00822383247212
• UDI-Public: 00822383247212
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 09/06/2022
• Report Date (Section F): 09/06/2022

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: RTL12202KDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/02/2022
• Event Location: Home
• Date Report to Manufacturer: 09/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 95 KG
• Date Report Sent to FDA: 09/06/2022