MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD. DRIVE MEDICAL; TRANSFER BENCH

Model Number	12011KD-1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a transfer bench by an end user, who stated that he sustained "bleeding and injury" while transferring out of his tub.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.
Event or Problem Description
Bliss healthcare was notified of an incident involving a transfer bench by an end user, who stated that he sustained "bleeding and injury" while transferring out of his tub.Drive contacted the end user's wife, and she reported that the end user fell but did not sustain any injury.The end user's wife also reported that the end user has died since the incident, but that there was no link between the fall and his death.Drive will not be able to perform a product evaluation since the product has been discarded.Drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE MEDICAL
• Common Device Name: TRANSFER 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: 15995352
• Report Number: 2438477-2022-00124
• Device Sequence Number: 6209108
• Product Code: ILS
• UDI-Device Identifier: 00822383224916
• UDI-Public: 822383224916
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023
• Report Date (Section F): 05/01/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 12011KD-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/18/2022
• Event Location: Home
• Date Report to Manufacturer: 05/08/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 05/01/2023
• 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: Death
• Patient Sex: Male
• Patient Weight: 69 KG
• Date Report Sent to FDA: 05/01/2023