MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD DRIVE; ADAPTOR, HYGIENE

Model Number	12005KDC-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a transfer bench/commode by letter received from an attorney, which stated that the end user "sustained injuries in an incident involving your unit." the attorney later reported that immediately after having assembled it with his wife, "one of the legs fell out" during use, and caused the end user to sustain a bone hematoma, which later resulted in an above-the-knee amputation of his leg.It was reported that the amputation was a second one, and further information regarding the condition that led to the prior amputation(s) was not provided.Drive is currently investigating the incident, including communicating with the attorney to gain additional information regarding the reported event and inspect the product, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ADAPTOR, HYGIENE
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO. LTD; no.61 &96 zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 17877363
• Report Number: 2438477-2023-00130
• Device Sequence Number: 7173059
• Product Code: ILS
• UDI-Device Identifier: 00822383231303
• UDI-Public: 00822383231303
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2023
• Report Date (Section F): 10/05/2023

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: 12005KDC-1
• Device Catalogue Number: 12005KDC-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/08/2023
• Event Location: Home
• Date Report to Manufacturer: 10/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2023
• 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: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 10/05/2023